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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01132807 |
Purpose
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 together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well chemotherapy based on PET scan works in treating patients with stage I or stage II Hodgkin lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Drug: ABVD regimen Drug: BEACOPP regimen Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate Other: laboratory biomarker analysis Procedure: computed tomography Radiation: fludeoxyglucose F 18 Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma |
| Estimated Enrollment: | 149 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* Hodgkin lymphoma
Measurable disease by physical examination or imaging studies
Lesions that are considered intrinsically non-measurable include:
PATIENT CHARACTERISTICS:
Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL
No "currently active" second malignancy other than nonmelanoma skin cancers
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for Hodgkin lymphoma
Contacts and Locations
Show 62 Study Locations| Principal Investigator: | David J. Straus, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01132807 History of Changes |
| Other Study ID Numbers: | CDR0000672913, CALGB-50604 |
| Study First Received: | May 27, 2010 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Unspecified |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma adult favorable prognosis Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult unfavorable prognosis Hodgkin lymphoma |
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Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Cyclophosphamide Dacarbazine Etoposide Prednisone Procarbazine |
Vinblastine Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antineoplastic Agents, Phytogenic |