Clinical trial NCT00003408: Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
Official title: Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-05-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation with biological therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim, interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
Study officials:
affiliation: Cancer Treatment Centers of America
name: Anastasios Raptis, MD
role: STUDY_CHAIR
References: