Phase 2
N=97
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00255723 ↗Enrolled (actual)
97
Serious AEs
26.8%
Results posted
Feb 2016
Primary outcome: Primary: Overall Objective Response — 45; 31; 6; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); etoposide (Drug); ifosfamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Objective Response |
45; 31; 6; 1; 3; 7 | — |
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
- Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology will be excluded.
- Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site
- Failure of doxorubicin or nitrogen mustard containing front-line therapy
- 18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease
- Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
- Adjusted diffusing capacity of greater than 50% on pulmonary function testing, measured since last chemotherapy
- Serum creatinine 1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
- ANC>1000/μl and Platelets>50,000/μl
- Total bilirubin < than or = to 2.0 mg/dl in the absence of a history of Gilbert's disease.
- Females of childbearing age must be on an acceptable form of birth control.
- Age between 18 and 72
- HIV I and II negative.
- Patients or their guardians must be capable of providing informed consent.
Exclusion Criteria
Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma
- Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine
- Hepatitis B surface antigen positive.
- Known pregnancy or breast-feeding.
- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, will preclude administering chemotherapy safely.
- History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix
Data sourced from ClinicalTrials.gov (NCT00255723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.