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Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004169
  Purpose

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
Lymphoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase I

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma Radiation Therapy
Drug Information available for: Cyclophosphamide Etoposide Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004169

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Leo I. Gordon, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009