Trial Outcomes & Findings for Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors (NCT NCT00467051)

Last Updated: 2018-08-29

Results Overview

Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, Biological Therapy) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, Biological Therapy) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
Overall Study Adverse Event	2

Baseline Characteristics

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, Biological Therapy) n=20 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	13.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Biological Therapy) n=20 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Responder	12 participants
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Non-Responder	8 participants

SECONDARY outcome

Timeframe: Two cycles of chemotherapy; expected to be 42 days of treatment.

Population: All eligible patients.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Biological Therapy) n=20 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.	18 Participants

Adverse Events

Treatment (Chemotherapy, Biological Therapy)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy, Biological Therapy) n=20 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
Psychiatric disorders Agitation	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Alanine aminotransferase increased	10.0% 2/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders Anemia	40.0% 8/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Aspartate aminotransferase increased	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders Ataxia	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Bladder infection	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders Cardiac disorders - Other	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders Confusion	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders Febrile neutropenia	25.0% 5/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypokalemia	15.0% 3/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hyponatremia	10.0% 2/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders Hypophosphatemia	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders Hypotension	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations Infections and infestations - Other	20.0% 4/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders Intracranial hemorrhage	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Lymphocyte count decreased	25.0% 5/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders Nail loss	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders Nervous system disorders - Other	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Neutrophil count decreased	60.0% 12/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Oral hemorrhage	5.0% 1/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations Platelet count decreased	45.0% 9/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders Vomiting	10.0% 2/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations White blood cell decreased	70.0% 14/20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER