Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

NCT ID: NCT00002931

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-02-28
• Study Completion Date: 2014-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.

Detailed Description

OBJECTIVES:

• Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer.
• Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.

Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.

Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.

Surgery may be performed after course 2 if indicated.

PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.

Conditions

Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HD Chemo and Auto Stem Cells

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.

carboplatin

Intervention Type: DRUG

AUC=7, daily X 3

etoposide

Intervention Type: DRUG

20 mg/kg by 2 hours infusion daily X 3

ifosfamide

Intervention Type: DRUG

3 gm/m2 IV over 30 minutes X 3 days

paclitaxel

Intervention Type: DRUG

425 mg/m2 as 24 hour continuous infusion

autologous bone marrow transplantation

Intervention Type: PROCEDURE

Given in two divided infusions on day -2 and day 0

bone marrow ablation with stem cell support

Intervention Type: PROCEDURE

Two cycles of high dose chemotherapy followed by stem cell reinfusion

Interventions

filgrastim

5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.

Intervention Type: BIOLOGICAL

carboplatin

AUC=7, daily X 3

Intervention Type: DRUG

etoposide

20 mg/kg by 2 hours infusion daily X 3

Intervention Type: DRUG

ifosfamide

3 gm/m2 IV over 30 minutes X 3 days

Intervention Type: DRUG

paclitaxel

425 mg/m2 as 24 hour continuous infusion

Intervention Type: DRUG

autologous bone marrow transplantation

Given in two divided infusions on day -2 and day 0

Intervention Type: PROCEDURE

bone marrow ablation with stem cell support

Two cycles of high dose chemotherapy followed by stem cell reinfusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category
• Bidimensionally measurable disease with measurements performed within 21 days of study entry
• Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 120,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.6 mg/dL
• SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
• No active hepatitis or cirrhosis

Renal:

• Creatinine clearance at least 70 mL/min

Cardiovascular:

• Ejection fraction (MUGA or echocardiogram) normal
• No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment

Pulmonary:

• PaO_2 at least 70 mm Hg
• FEV_1 at least 2 L or 75%
• No history of bleomycin associated or serious lung disease

Neurologic:

• No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study
• Prior peripheral neuropathy requires consultation with principal investigator

Other:

• No significant active medical illness precluding study or survival
• Not HIV positive
• No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer
• No prior hematologic malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow or stem cell rescue with high-dose chemotherapy

Chemotherapy:

• Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue
• No prior paclitaxel

Endocrine therapy:

• Not specified

Radiotherapy:

• No concurrent radiotherapy during study

Surgery:

• Recovered from prior surgery

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sumanta Pal, MD

Role: STUDY_CHAIR

City of Hope Medical Center

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Countries

United States

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-96126

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1136

Identifier Type: -

Identifier Source: secondary_id

CDR0000065365

Identifier Type: REGISTRY

Identifier Source: secondary_id

96126

Identifier Type: -

Identifier Source: org_study_id