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Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease


OBJECTIVES:

Primary

- Determine the 3-year progression-free survival of patients with progressive or
recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation
(2 courses of high-dose therapy with autologous stem cell rescue).

- Determine the response rate in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk
[primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).

- Salvage therapy (for patients with relapsed disease after achieving a previous complete
response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.

- Autologous hematopoietic stem cell collection: Patients undergo autologous
hematopoietic stem cell collection. Patients with an inadequate number of collected
stem cells are removed from the study.

- First preparative regimen: Patients receive high-dose melphalan IV continuously over 16
hours on day -1.

- First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on
day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on
day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients
proceed to second preparative regimen.

- Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on
days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over
2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second
autologous SCT (day 0).

- Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also
receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and
continuing until blood counts recover.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 3 years

Outcome Time Frame:

Up to three years after second transplant

Safety Issue:

No

Principal Investigator

Brian J. Bolwell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CCF5386

NCT ID:

NCT00265889

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195