Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 1989 |
OBJECTIVES:
- Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
- Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
- Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
- Determine the acute toxicity associated with this treatment.
- Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.
OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.
- Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed Hodgkin's lymphoma of any histology
Unfavorable disease required
- Clinical stage IIIA, IIIB, IV, or IIB (non-bulky)
Locally extensive stage I or II with either of the following:
- Mediastinal mass greater than 1/3 the maximum intrathoracic diameter
- Two or more extranodal sites
PATIENT CHARACTERISTICS:
Age:
- 18 to 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior malignancy except nonmelanomatous skin cancer
- No significant concurrent illness that precludes protocol participation
PRIOR CONCURRENT THERAPY:
- No prior treatment for Hodgkin's lymphoma
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Study Chair: | Sandra J. Horning, MD | Stanford University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002715 History of Changes |
| Other Study ID Numbers: | CDR0000064551, SUMC-G2/G3, NCI-H96-0806 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Mechlorethamine Etoposide Prednisone Vinblastine Vincristine |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Anti-Inflammatory Agents Tubulin Modulators |
ClinicalTrials.gov processed this record on May 19, 2013