Phase I Study of HeFi-1 to Treat Cancers With CD30 Protein

NCT00048880 | Completed Phase 1

• 2 other identifiers: 03003803-C-0038
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Some cancers, such as Hodgkin's disease, anaplastic large cell lymphoma and others, have a protein on the surface of the cancer cell called CD30.
• HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer cells that can cause them to die. Objectives:
• To determine the highest dose of HeFi-1 that can safely be given to patients with tumors that have the CD30 protein.
• To determine the response of the tumor to treatment with HeFi-1. Eligibility:
• Patients 18 years of age and older with Hodgkin's disease, anaplastic large cell lymphoma, cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs of tumor growth or recurrence following standard treatment
• Patients' tumor cells must have the CD30 protein. Design:
• Groups of three patients are treated with increasingly higher doses of HeFi-1 (ranging from 0.5 to 5 mg/kg) to determine the highest safe dose.
• HeFi-1 is infused through a vein on 4 days, followed by 2 days of rest over a 10-day period. Patients may receive up to 2 treatment courses if they show some response and do not have severe side effects.
• Blood samples are collected several times during the study to determine safety. A lymph node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer cells in the test tube, and a bone marrow biopsy may be done at the end of treatment if the bone marrow was positive for tumor cells at the beginning of treatment.

Conditions

Neoplasms

Keywords

Anaplastic Large Cell Lymphoma; Monoclonal Antibody; CD30; Antibody Saturation; Apoptosis; Flow Cytometry; Cancer

Interventions

HeFi-1 Monoclonal Antibody DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patients must have a histologically confirmed diagnosis of malignancy by department of pathology at the enrolling institution.
• Tumor cells must express CD30. CD30 expression will be verified by immunohistochemistry. At least 30% of tumor cells must be CD30 positive. CD30 staining will be performed on existing tissue blocks and on fresh tumor tissue if a biopsy is performed.
• Patients must have measurable or evaluable disease.
• The patient must have a granulocyte count of at least 1000/mm(3) and a platelet count of 50,000/mm(3) without transfusion.
• Patients must have a creatinine of less than 2.0 mg/dL.
• Omission of cyotoxic chemotherapy and systemic steroids for 3 weeks prior to entry into the trial is required. Topical and inhaled steroids will be permitted.
• Patients must have a life expectancy of greater than 2 months.
• Eligible patients must be greater than or equal to 18 years old. There is no upper age limit.
• Patients must have SGOT and SGPT value less than or equal to 2.0-fold greater than the upper limit of normal and bilirubin less than or equal to 2.0 mg/dL.
• Patients must be able to understand and sign an Informed Consent form.
• Karnofsky Performance Status greater than or equal to 70%.

You may not qualify if:

• Patients with central nervous system disease as assessed by clinical examination. If the clinical findings suggest the presence of CNS disease a lumbar puncture should be done.
• Pregnant and nursing patients are not eligible for the study because the effects of HeFi-1 on the developing fetus and the nursing infant are unknown. All patients must agree to use effective contraceptive measures while receiving therapy and for two weeks afterwards.
• HIV positive patients are excluded from the study because the toxicity may be different in this population.
• Hepatitis B surface antigen positive and Hepatitis C antibody positive patients are excluded because the toxicity of therapy may be different in this population.
• Patients who previously received murine monoclonal antibody therapy are ineligible.
• Patients who are HAMA positive.
• Patients with significant renal, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease should be excluded.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• Catane R, Longo DL. Monoclonal antibodies for cancer therapy. Isr J Med Sci. 1988 Sep-Oct;24(9-10):471-6.

  PMID: 3060441 BACKGROUND

• Grillo-Lopez AJ, White CA, Varns C, Shen D, Wei A, McClure A, Dallaire BK. Overview of the clinical development of rituximab: first monoclonal antibody approved for the treatment of lymphoma. Semin Oncol. 1999 Oct;26(5 Suppl 14):66-73.

  PMID: 10561020 BACKGROUND

• Shak S. Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer. Herceptin Multinational Investigator Study Group. Semin Oncol. 1999 Aug;26(4 Suppl 12):71-7.

  PMID: 10482196 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Lymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 8, 2002
• First Posted: November 11, 2002
• Study Start: November 5, 2002
• Primary Completion: July 2, 2008
• Study Completion: July 2, 2008
• Last Updated: July 2, 2017

Record last verified: 2010-03-05

Locations

US (2)