Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease - Article
Clinical Trial: Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease
This study is no longer recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|recurrent childhood Hodgkin's disease |
recurrent adult Hodgkin's disease
| Drug: carboplatin |
|Phase I |
MedlinePlus related topics: Hodgkin's Disease
Study Type: Interventional
Study Design: Treatment
Study start: October 1999
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.
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
PROTOCOL ENTRY CRITERIA:
- 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
- See Disease 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
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, 60611, United States
Leo I. Gordon, Study Chair, Robert H. Lurie Cancer Center
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
Cache Date: April 9, 2005