Trial Outcomes & Findings for Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers (NCT NCT00141765)
NCT ID: NCT00141765
Last Updated: 2014-06-20
Results Overview
The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 year post transplant
Results posted on
2014-06-20
Participant Flow
Participant milestones
| Measure |
Myeloablative Chemotherapy With Stem Cell Rescue
Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
Baseline characteristics by cohort
| Measure |
Myeloablative Chemotherapy With Stem Cell Rescue
n=25 Participants
Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation
|
|---|---|
|
Age, Continuous
|
6 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 year post transplantThe primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.
Outcome measures
| Measure |
Myeloablative Chemotherapy With Stem Cell Rescue
n=25 Participants
Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation
|
|---|---|
|
Percent of Participants With Progression Free Survival at 1 Year
|
58 percentage of participants
|
Adverse Events
Myeloablative Chemotherapy With Stem Cell Rescue
Serious events: 19 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Myeloablative Chemotherapy With Stem Cell Rescue
n=25 participants at risk
Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation
|
|---|---|
|
Gastrointestinal disorders
Mucocitis
|
40.0%
10/25
|
|
Infections and infestations
Infection
|
44.0%
11/25
|
|
Investigations
Thrombocytopenia
|
4.0%
1/25
|
|
General disorders
Death
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
1/25
|
|
General disorders
Fever
|
24.0%
6/25
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
8.0%
2/25
|
|
Immune system disorders
Febrile Transfusion Reaction
|
4.0%
1/25
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.0%
1/25
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
8.0%
2/25
|
|
General disorders
Graft Failure
|
4.0%
1/25
|
|
Cardiac disorders
Hypertension
|
4.0%
1/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Relapse
|
4.0%
1/25
|
|
Renal and urinary disorders
Renal Failure
|
4.0%
1/25
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hypcalcemia
|
8.0%
2/25
|
|
Gastrointestinal disorders
Enterocolitis
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25
|
Other adverse events
| Measure |
Myeloablative Chemotherapy With Stem Cell Rescue
n=25 participants at risk
Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Stem Cell Rescue: autologous stem cell transplantation
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
32.0%
8/25
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
5/25
|
|
Investigations
Total Bilirubin
|
24.0%
6/25
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.0%
3/25
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.0%
2/25
|
|
Investigations
ALK
|
12.0%
3/25
|
|
Investigations
AST
|
24.0%
6/25
|
|
Investigations
ALT
|
20.0%
5/25
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.0%
4/25
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.0%
3/25
|
|
Gastrointestinal disorders
Esophagitis
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25
|
|
Gastrointestinal disorders
Mucocitis
|
8.0%
2/25
|
|
Ear and labyrinth disorders
Hearing Loss
|
8.0%
2/25
|
Additional Information
Dr. John E. Levine, MD
University of Michigan Cancer Center
Phone: 734-936-8456
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place