High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors
3 other identifiers
interventional
174
1 country
1
Brief Summary
This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2006
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2018
CompletedResults Posted
Study results publicly available
April 22, 2021
CompletedApril 22, 2021
March 1, 2021
12 years
September 27, 2007
March 23, 2021
March 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years
Secondary Outcomes (3)
Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
Up to 100 days after transplantation
Response Rate (Complete Remission)
At 100 days
Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
Patients are followed up to maximum of 12 years
Study Arms (7)
Regimen CBV (patients with HL or NHL)
EXPERIMENTALPatients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0.
Regimen M200/M120 (patients with MM or amyloidosis)
EXPERIMENTALPatients receive 200 or 120 mg/m\^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.
Regimen BuC2iv (patients with ALL, AML, HL, or NHL)
EXPERIMENTALPatients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0.
Regimen CT6 (patients with ALL)
EXPERIMENTALPatients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0.
Regimen CTtCp (patients with other solid tumors)
EXPERIMENTALPatients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0.
Regimen VCp (patients with testicular cancer)
EXPERIMENTALPatients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0.
Regimen TtC1500/ECpM (patients with NBL or SRBCT)
EXPERIMENTALPatients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo ASCT
Undergo tandem ASCT
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
- Recurrent or refractory disease or disease at high risk for recurrence
- Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
- Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
- Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
- Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
- Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
- Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma \[CLL\], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
- Amyloidosis: primary or previously treated
- Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
- Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
- Performance status 0-2 (Karnofsky performance status \[KPS\] \>= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
- Life expectancy \> 2 months
- Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) \>= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
- Cardiac ventricular ejection fraction \>= 50% by radionuclide ventriculogram or echocardiogram
- +13 more criteria
You may not qualify if:
- Uncontrolled or severe cardiovascular disease, including recent (\< 6 months) myocardial infarction, congestive heart failure, symptomatic angina, life-threatening arrhythmia or hypertension
- Active bacterial, viral, or fungal infection
- Active peptic ulcer disease
- Uncontrolled diabetes mellitus
- No serious medical or psychiatric illness
- Not pregnant
- No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary
- Allogeneic BMT not possible, or not desirable
- Age \> 65 years
- No compatible donor identified
- Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT
- Adequate bone marrow or blood stem cell dose obtained:
- For blood stem cells: total CD 34+ \>= 2 x 10\^6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of \>= l x 10\^8/kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Theresa Hahn, PhD
- Organization
- Roswell Park Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Philip McCarthy
Roswell Park Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
June 29, 2006
Primary Completion
July 9, 2018
Study Completion
July 9, 2018
Last Updated
April 22, 2021
Results First Posted
April 22, 2021
Record last verified: 2021-03