Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Risk-Adapted High Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients With Relapsed and Primary Refractory Hodgkin's Lymphoma
2 other identifiers
interventional
98
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Apr 2004
Typical duration for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
February 1, 2016
CompletedFebruary 1, 2016
December 1, 2015
8.3 years
November 18, 2005
December 22, 2015
December 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Objective Response
Overall objective response to therapy Complete remission/unconfirmed (CRu) This includes patients who meet criteria for CR with the following exceptions: 1\. A residual lymph node mass \> 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR) 1. Any decrease in lymph nodes and nodal-based masses 2. Any decrease in PET avidity (however, residual FDG uptake is present) 3. Involving organs involved prior to therapy must have diminished in size. 4. No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease 1\. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy
3 years
Study Arms (2)
Cytoreductive chemotherapy group 1
EXPERIMENTALPatients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
Cytoreductive chemotherapy group 2
EXPERIMENTALPatients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- F-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 \< than or = to 1.5 mg/dl; if 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (2)
Driessen J, Zwezerijnen GJC, Schoder H, Kersten MJ, Moskowitz AJ, Moskowitz CH, Eertink JJ, Heymans MW, Boellaard R, Zijlstra JM. Prognostic model using 18F-FDG PET radiomics predicts progression-free survival in relapsed/refractory Hodgkin lymphoma. Blood Adv. 2023 Nov 14;7(21):6732-6743. doi: 10.1182/bloodadvances.2023010404.
PMID: 37722357DERIVEDMoskowitz CH, Matasar MJ, Zelenetz AD, Nimer SD, Gerecitano J, Hamlin P, Horwitz S, Moskowitz AJ, Noy A, Palomba L, Perales MA, Portlock C, Straus D, Maragulia JC, Schoder H, Yahalom J. Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma. Blood. 2012 Feb 16;119(7):1665-70. doi: 10.1182/blood-2011-10-388058. Epub 2011 Dec 19.
PMID: 22184409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Craig Moskowitz
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- STUDY CHAIR
Craig Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 21, 2005
Study Start
April 1, 2004
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 1, 2016
Results First Posted
February 1, 2016
Record last verified: 2015-12