Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Launched by TEMPLE UNIVERSITY · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) followed by syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell (PBSC) rescue in patients with relapsed or refractory stage I-IV Hodgkin's lymphoma.
* Determine the overall response rate and survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the differences in the rate of engraftment, response, and survival of patients treated with bone marrow vs PBSC transplantation.
* Determine the re...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically proven stage I-IV Hodgkin's lymphoma
• * Must have refractory or relapsed disease, defined by 1 of the following:
• • Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy
• • Disease in second or greater remission
• • Patients should be encouraged to undergo transplantation prior to a third salvage regimen
• • Patients previously treated with multiple regimens considered on a case-by-case basis
• • No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy
• • Patients who respond to second-line chemotherapy may be eligible
• • Stable residual masses after conventional-dose chemotherapy not considered treatment failures
• • Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake
• • Syngeneic marrow transplantation offered to patients with consenting identical twin donor
• • No CNS involvement by lymphoma
• PATIENT CHARACTERISTICS:
• Age:
• • 15 to 60 (selected patients up to age 70 may be eligible)
• Performance status:
• • ECOG 0-2
• Life expectancy:
• • Not specified
• Hematopoietic:
• • WBC greater than 4,000/mm\^3
• • Absolute neutrophil count greater than 2,000/mm\^3
• • Platelet count greater than 100,000/mm\^3
• Hepatic:
• • Bilirubin less than 2.0 mg/dL
• • SGOT and SGPT less than 2 times upper limit of normal
• • Albumin greater than 3.0 g/dL
• Renal:
• * Must meet 1 of the following criteria:
• • Creatinine less than 1.8 mg/dL
• • Creatinine clearance greater than 60 mL/min
• • BUN less than 20 mg/dL
• Cardiovascular:
• • Left ventricular ejection fraction at least 50%
• Pulmonary:
• • DLCO, FEV_1, and FVC greater than 50% of predicted OR
• • Resting pO_2 greater than 70 mm Hg on room air
• Other:
• • HIV negative
• • No severe neurologic or emotional disorders
• • No active infection
• • No other disease that would limit life expectancy
• • Not pregnant
• • Fertile patients must use effective contraception
• • Adequate psychosocial support required
• PRIOR CONCURRENT THERAPY:
• • Biologic therapy
• • Not specified
• • Chemotherapy
• • See Disease Characteristics
• • Endocrine therapy
• • Not specified
• • Radiotherapy
• • Not specified
• • Surgery
• • Not specified

Trial Officials