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Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma


Phase 1
N/A
N/A
Not Enrolling
Both
Breast Neoplasms, Lymphoma, Neoplasm Metastasis, Testicular Neoplasms

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Trial Information

Feasibility Study of Interleukin 1-Alpha With Ifosfamide, CBDCA, and Etoposide With Autologous Bone Marrow Transplant in Metastatic Carcinoma and Lymphoma


This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with
autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid
cancers. The initial goal of this study was to define the toxicity of interleukin-1
administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated
with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A
second cohort of 18 patients also received G-CSF and engraftment was further shortened in
some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and
G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.

Inclusion Criteria


A history of pathologically documented (clinical documentation may be acceptable at
relapse):

Breast cancer: metastatic or locally advanced (Stage III/IV) with stable minimal (less
than or equal to 2 cm) residual disease after 2 cycles of appropriate combination
chemotherapy may start BMT.

Non-Hodgkin's lymphomas: all stages of relapsed or induction failure (FSC, FM, FL, DSC,
DL, DM, DIDL, IBL, LBL, SNC) after appropriate chemotherapy.

Hodgkin's lymphomas: all stages of chemotherapy induction failures, first relapse less
than or equal to 1 year from chemotherapy induced remission, first relapse greater than 1
year from chemotherapy induced remission if there is extranodal involvement at relapse,
greater than or equal to 2 relapses (one may be after radiation) following appropriate
combination chemotherapy, or relapse at any time from radiation therapy with stage IIB,
IIIB, IV A/B.

Testicular cancer: all stages of relapsed or induction failure following appropriate
combination chemotherapy.

No evidence of central nervous system cancer.

Patients must be between 18 and 65 years old.

Normal cardiac function: no history of angina pectoris, myocardial infarction, congestive
heart failure or ejection fraction less than 40 percent.

Creatinine clearance greater than or equal to 45 cc/min/m(2), bilirubin less than or equal
to 1.5, SGOT less than or equal to 2x normal, and normal PT, PTT and calcium.

Negative HIV serology and hepatitis B surface antigen.

Adequate pulmonary function (PFTs are only obtained in patients with clinical evidence of
pulmonary dysfunction): DLCO greater than 50 percent, compensated for Hgb, FEV 1 greater
than 55 percent and PO2 greater than 60.

Negative bilateral bone marrow biopsies prior to bone marrow harvest.

No evidence of metastatic disease to the pelvis on plain film or bone scan.

Karnofsky performance status greater than or equal to 70 and a life expectancy greater
than or equal to 60 days.

No evidence of pregnancy or risk of pregnancy at the time of transplantation in women.

Ability to give informed consent.

Good psychiatric and medical risk.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

910156

NCT ID:

NCT00001270

Start Date:

June 1991

Completion Date:

March 2000

Related Keywords:

  • Breast Neoplasms
  • Lymphoma
  • Neoplasm Metastasis
  • Testicular Neoplasms
  • Chemotherapy
  • High Dose
  • Protection
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Lymphoma
  • Neoplasm Metastasis
  • Testicular Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892