Clinical Trial: Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy

This study is currently recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in treating patients who have lymphoma, colon cancer, or prostate cancer that has not responded to vaccine therapy.

Condition Treatment or Intervention Phase
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent colon cancer
recurrent prostate cancer
recurrent mantle cell lymphoma
 Drug: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Colorectal Cancer;   Lymphatic Diseases;   Lymphoma;   Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-CTLA4) in Patients With Follicular or Mantle Cell Lymphoma, Colon Cancer, or Prostate Cancer Refractory to Vaccine Therapy

Further Study Details: 

OBJECTIVES: Primary

  • Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate cancer refractory to vaccine therapy. (part I)
  • Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma. (part II)

Secondary

  • Determine the ability of this drug to increase tumor-specific T-cell responses in these patients.
  • Determine the ability of this drug to produce clinical tumor response in these patients.
  • Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+ cells) in these patients.

OUTLINE: This is a pilot, partial dose-escalation study.

  • Part I (patients with prostate or colon cancer or follicular or mantle cell lymphomas): Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) IV over 90 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Patients receive MDX-CTLA4 as in part I. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every other month.

PROJECTED ACCRUAL: A maximum of 18-24 patients (4 per tumor type for part I and 6-12 with follicular lymphoma for part II) will be accrued for this study within 1.5 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • WBC at least 2,500/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Hematocrit at least 30%

Hepatic

  • Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease)
  • SGOT and SGPT no greater than 3 times upper limit of normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine no greater than 2.0 mg/dL

Immunologic

  • HIV negative
  • Rheumatoid factor negative if history or evidence of arthritis
  • Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease
  • No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, or lupus erythematosus)
  • No positive antibody titers to autoimmune diseases
  • Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease
  • No active infection

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics
  • Recovered from prior vaccine therapy
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study
  • Patients in part II of study may have had up to 4 prior treatments with MDX-CTLA4
  • No concurrent vaccine therapy
  • No concurrent infliximab

Chemotherapy

  • At least 4 weeks since prior cytotoxic chemotherapy
  • No concurrent mercaptopurine, methotrexate, or cyclophosphamide

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior steroids
  • No concurrent systemic, inhaled, or topical steroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • At least 4 weeks since prior major surgery

Other


Location and Contact Information


Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Patient Recruitment  888-NCI-1937 

Study chairs or principal investigators

John Edward Janik, MD,  Study Chair,  NCI - Metabolism Branch;MET   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000257563; NCI-02-C-0284; NCI-5744; NCT00047164
Record last reviewed:  February 2005
Last Updated:  March 3, 2005
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00047164
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005