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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004169 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease.
Condition | Intervention | Phase |
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Lymphoma |
Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease |
Study Start Date: | October 1999 |
OBJECTIVES: I. Determine the toxicity and response to high dose chemotherapy and peripheral blood stem cell support in patients with recurrent or refractory Hodgkin's disease. II. Determine the maximum tolerated dose of etoposide when combined with carboplatin and cyclophosphamide in these patients.
OUTLINE: This is a dose escalation study of etoposide. Patients undergo total nodal radiotherapy twice a day on days -35 to -31, -28 to -24, and then radiotherapy boost once a day on days -21 to -17. Patients then receive etoposide IV continuously and carboplatin IV continuously on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Autologous peripheral blood stem cells are infused on day 0. Patients who have received prior extensive radiation (at least 2000 cGy to any site) only receive chemotherapy and peripheral blood stem cell infusion. Cohorts of 4-8 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 4 or 2 of 8 patients experience dose limiting toxicity. Patients are followed every 1-3 months for 2 years, then every 3 months until death.
PROJECTED ACCRUAL: At least 4 patients will be accrued for this study.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard therapy OR Relapsed following initial complete remission Measurable or evaluable disease Hepatic involvement must be histologically proven to be considered sole area of measurable disease If referred following successful induction therapy, measurable or evaluable disease not required No CNS disease
PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the past 3 months No significant arrhythmia requiring medication Ejection fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude chemotherapy HIV negative No clinical evidence of AIDS
PRIOR CONCURRENT THERAPY: See Disease Characteristics
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611 |
Study Chair: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067413, NU-93H2, NCI-G99-1636 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004169 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
Immunoproliferative Disorders Immunologic Factors Hodgkin Lymphoma, Childhood Hodgkin Lymphoma, Adult Hodgkin's Disease Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate |
Recurrence Lymphatic Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Lymphoma Hodgkin Disease Etoposide |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Hodgkin Disease Lymphoma |