Overview

Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Busulfan
Cyclophosphamide
Etoposide
Melphalan
Criteria
DISEASE CHARACTERISTICS:

- Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:

- Disease progression during initial first line chemotherapy

- Complete response lasting ≤ 90 days after induction

- Partial response lasting ≤ 90 days after induction

- First recurrence/progression with the duration of initial response ≤ 12 months
after completion of chemotherapy NOTE: *There must be unequivocal radiological
evidence of recurrent or progressive disease if biopsy was not obtained at time
of disease recurrence/progression

- No clonal abnormalities in marrow collection

- Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days
prior to stem cell collection

- Must have adequate sections of original diagnostic specimen available for review

- Needle aspirations or cytologies are not adequate

- No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5
years)

- No CNS involvement

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 50-100%

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's
lymphoma

Renal

- Creatinine clearance ≥ 60 mL/min

- Creatinine ≤ 2.0 times ULN

Cardiovascular

- Ejection fraction ≥ 45% by 2-D echocardiogram

- No significant active cardiac disease

Pulmonary

- Adequate pulmonary function

- DLCO ≥ 45%

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer

- No known HIV or AIDS infection

- No active bacterial, fungal, or viral infection

- No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics