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Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation


Phase 1
18 Years
65 Years
Not Enrolling
Both
Breast Cancer, Lymphoma

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Trial Information

Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor (SCF) for Patients With Lymphoma or Breast Cancer After Autologous Transplantation


OBJECTIVES: I. Determine the safety and maximum tolerated dose of interleukin-2 (IL-2) and
stem cell factor (SCF) following autologous peripheral blood stem cell transplantation in
patients with non-Hodgkin's lymphoma or advanced breast cancer. II. Determine the
effectiveness of filgrastim (G-CSF) and SCF as mobilizing agents in these patients.

OUTLINE: This is a dose escalation study of stem cell factor (SCF). Patients receive
filgrastim (G-CSF) subcutaneously (SC) followed by SCF SC daily for 7-10 days. Beginning on
the fifth day of G-CSF and SCF injections, peripheral blood stem cells (PBSC) are collected
over several days. PBSC are later reinfused and patients receive G-CSF SC daily until
hematopoietic recovery. At least 30 days but no later than 110 days following transplant,
patients who did not experience adverse reactions to SCF during mobilization begin
posttransplant immunotherapy. Patients receive interleukin-2 SC daily and SCF SC 3 times
weekly for 6 weeks. Treatment continues in the absence of unacceptable toxicity or disease
progression. Cohorts of 3-6 patients receive escalating doses of SCF during posttransplant
immunotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting
toxicities. Patients are followed at 1 week, every 3 months for 1 year, and then every 6
months thereafter.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study within 1-1.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Hodgkin's disease, non-Hodgkin's lymphoma, or advanced stage
breast cancer Planned treatment is autologous peripheral blood stem cell transplantation
No T-cell lymphomas Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance
status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic:
Not specified Renal: Not specified Immunologic: No history of seasonal or recurrent asthma
within the past 5 years No concurrent asthmatic symptoms (e.g., wheezing) related to a
current respiratory tract infection No anaphylactic/anaphylactoid type event manifested by
disseminated urticaria, laryngeal edema, hypotension, and/or bronchospasm (e.g., food or
insect venom) within the past 5 years Drug allergies manifested solely by rash allowed No
history of angioedema or recurrent urticaria lasting longer than 14 days No history of
hereditary or acquired angioedema No known allergy to E. coli derived products Other: Not
pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 week
since prior hematopoietic growth factors Chemotherapy: Not specified Endocrine therapy: No
concurrent steroids Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other:
No concurrent beta adrenergic blocking agents No concurrent therapeutic antibiotics
posttransplant No concurrent IV hyperalimentation or IV fluids posttransplant

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Linda J. Burns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Federal Government

Study ID:

1999LS022

NCT ID:

NCT00005993

Start Date:

May 1999

Completion Date:

July 2005

Related Keywords:

  • Breast Cancer
  • Lymphoma
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • recurrent adult Hodgkin lymphoma
  • stage III grade 3 follicular 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 3 follicular 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
  • noncontiguous stage II grade 3 follicular 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
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Breast Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

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