Clinical Trial: Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent childhood Hodgkin's disease
recurrent adult Hodgkin's disease
 Drug: carboplatin
 Drug: cyclophosphamide
 Drug: etoposide
Phase I

MedlinePlus related topics:  Hodgkin's Disease

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of High Dose Chemotherapy and Radiotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Recurrent or Refractory Hodgkin's Disease

Further Study Details: 

Study start: 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.

PROTOCOL 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

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--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

Location Information


Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States

Study chairs or principal investigators

Leo I. Gordon,  Study Chair,  Robert H. Lurie Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067413; NU-93H2; NCI-G99-1636
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004169
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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