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Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor

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Trial Information

Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation


OBJECTIVES:

- Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and
interferon alfa following high dose chemotherapy and autologous stem cell rescue in
patients with high risk cancer.

- Determine the effect of this regimen on long-term leukocyte and platelet recovery
following high dose chemotherapy and stem cell rescue in these patients.

- Determine the cellular response to this regimen in these patients.

- Assess progression free and overall survival rates in these patients.

OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa.

Beginning 14 days after the autologous stem cell transplant, patients receive daily
subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous
interleukin-2 on days 3-7, followed by 1 week of rest. Patients then receive a subcutaneous
injection of interferon alfa three times a week for 3 weeks followed by one more week of
rest. Treatment is repeated for four courses.

Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa
until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which
no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose
escalation occurs in courses 2-4, in the absence of dose limiting toxicity.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following cancers and undergoing high dose chemotherapy with
autologous stem cell rescue (ASCR):

- Metastatic breast cancer

- Multiple myeloma

- Hodgkin's disease

- Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma

- Acute myelogenous leukemia beyond first remission

- Acute lymphoblastic leukemia beyond first remission

- Ovarian cancer

- Refractory malignancy and measurable or evaluable disease (at time of ASCR)

- Hormone receptor status:

- Not specified

- 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:

- Not specified

Menopausal status:

- Not specified

Performance status:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Anastasios Raptis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Treatment Centers of America

Authority:

United States: Federal Government

Study ID:

CDR0000066418

NCT ID:

NCT00003408

Start Date:

April 1998

Completion Date:

March 2000

Related Keywords:

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • Testicular Germ Cell Tumor
  • stage IV breast cancer
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • refractory multiple myeloma
  • recurrent childhood rhabdomyosarcoma
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • chronic idiopathic myelofibrosis
  • childhood acute promyelocytic leukemia (M3)
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular teratoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and seminoma
  • refractory hairy cell leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent ovarian germ cell tumor
  • ovarian yolk sac tumor
  • ovarian embryonal carcinoma
  • ovarian polyembryoma
  • ovarian choriocarcinoma
  • ovarian immature teratoma
  • ovarian mature teratoma
  • ovarian monodermal and highly specialized teratoma
  • ovarian mixed germ cell tumor
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular 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 grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular 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 grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular 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
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle 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
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • previously treated childhood rhabdomyosarcoma
  • recurrent mycosis fungoides/Sezary syndrome
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neuroblastoma
  • Ovarian Neoplasms
  • Trophoblastic Neoplasms
  • Lymphoma, Large-Cell, Immunoblastic
  • Neoplasms, Germ Cell and Embryonal
  • Gestational Trophoblastic Neoplasms
  • Sarcoma

Name

Location

Midwestern Regional Medical CenterZion, Illinois  60099