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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 NON-HODGKIN'S LYMPHOMA (INTERMEDIATE AND HIGH-GRADE HISTOLOGIES)


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 NON-HODGKIN'S LYMPHOMA (INTERMEDIATE AND HIGH-GRADE HISTOLOGIES)


OBJECTIVES:

- Determine the curative potential of high-dose cyclophosphamide, etoposide, and
cisplatin (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral
blood stem cell rescue in patients with relapsed or refractory, stage I-IV,
intermediate- or high-grade non-Hodgkin's lymphoma.

- Determine the overall response rate and survival of patients treated with this regimen.

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

- Determine the differences in the rates of engraftment, response, and survival of
patients treated with bone marrow vs peripheral blood stem cell transplantation.

- Determine the response rate and survival of patients treated with consolidative
radiotherapy after recovery from transplantation.

- Determine the toxic effects of 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 and 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 relapsed or refractory, stage I-IV, intermediate- or high-grade
non-Hodgkin's lymphoma

- Eligible subtypes:

- Diffuse small cleaved cell

- Diffuse mixed (small and large cell)

- Diffuse large cell

- Large cell immunoblastic

- Lymphoblastic

- Small noncleaved cell

- High-grade histology patients should first be considered for Protocol TUHSC-1520

- Must have chemosensitive disease, defined by 1 of the following conditions:

- Response to initial chemotherapy without obtaining complete response
(CR)(refractory lymphoma)

- Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25%
for more than 1 month after completion of 1-3 courses of salvage chemotherapy
(chemosensitive relapse)

- No chemoresistant disease, defined by the following conditions:

- Unresponsive or progressive disease during initial chemotherapy

- Relapse after chemotherapy-induced CR if tumor volume not reduced by at least
25% after completion of 1-3 courses salvage chemotherapy (chemoresistant
relapse)

- No CNS involvement by lymphoma

- Syngeneic bone marrow transplantation offered to patients with consenting identical
twin donor NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has
been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will
replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 15 to 60 (physically fit patients up to age 70 may be considered)

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- AST and ALT not persistently greater than 2 times normal

Renal:

- Creatinine less than 1.8 mg/dL

Cardiovascular:

- Cardiac ejection fraction at least 45%

Pulmonary:

- DLCO, FEV_1, and FVC at least 50% predicted

- Resting pO_2 at least 70 mm Hg

Other:

- HIV negative

- No other concurrent disease that would limit life expectancy

- No active infection

- No severe neurologic or emotional disorders

- Not pregnant

- Fertile patients must use effective contraception

- Adequate psychological support available

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:

CDR0000078282

NCT ID:

NCT00002521

Start Date:

February 1993

Completion Date:

February 2000

Related Keywords:

  • Lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Fox Chase - Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442