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HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE


Phase 2
15 Years
70 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE


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 response rate and survival of patients treated with late consolidative
radiotherapy after recovery from transplantation.

- Determine the toxicity of late consolidative radiotherapy after recovery from
transplantation in these patients.

OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells
(PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a
qualifying identical twin donor. Patients without a syngeneic donor who have a history of
lymphomatous involvement of the bone marrow or are profoundly hypocellular undergo harvest
of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous
involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.

Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3
and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4.
Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem
cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)

After recovery from transplantation, eligible patients receive consolidative radiotherapy to
any site of prior bulk disease (greater than 5 cm) present at any time before
transplantation and any site of disease present at the time of transplantation.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kenneth F. Mangan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000078283

NCT ID:

NCT00002522

Start Date:

February 1993

Completion Date:

February 2002

Related Keywords:

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

Name

Location

Fox Chase - Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442