Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients with Refractory Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	NCI-03-C-0038 NCI-5750, 5750, NCT00048880

Objectives

1. Determine the toxicity and maximum tolerated dose of monoclonal antibody HeFi-1 in patients with refractory CD30-positive lymphoma.
2. Determine the frequency and time course of onset of development of human anti-mouse antibody in patients treated with this drug.
3. Correlate clinical tumor response with in vitro tumor apoptosis induction and sIL2-R levels in patients treated with this drug.
4. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed lymphoma that is refractory to standard therapy, including the following:
  • Hodgkin's lymphoma
    • Progressive disease after first-line chemotherapy
    • Refused or ineligible for bone marrow transplantation
    • No radiation therapy-only failure
  • Systemic anaplastic large cell lymphoma
    • Progressive disease after first-line chemotherapy
    • Refused or ineligible for bone marrow transplantation
  • Cutaneous T-cell lymphoma
    • No stage Ia disease
    • Progressive disease after first-line therapy
  • HTLV-1-positive T-cell lymphoma
    • No smoldering disease
    • Must have progressive disease after initial therapy



• At least 30% of tumor cells must be CD30 positive by immunohistochemistry



• Measurable or evaluable disease



• No CNS disease

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior murine monoclonal antibody therapy
• No other concurrent monoclonal antibody therapy
• No concurrent biological response modifiers
• No concurrent gammaglobulin

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior cytotoxic chemotherapy
• No concurrent investigational or approved anticancer chemotherapeutic agents

Endocrine therapy

• At least 3 weeks since prior systemic steroids
• No concurrent systemic steroids
  • Concurrent topical or inhaled steroids allowed

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• No concurrent drugs that affect lymphocytes
• No other concurrent investigational anticancer drugs

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 2 months

Hematopoietic

• Granulocyte count at least 1,000/mm³
• Platelet count at least 50,000/mm³ (transfusion-independent)

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• SGOT and SGPT no greater than 2 times upper limit of normal
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal

• Creatinine less than 2.0 mg/dL
• No significant renal disease

Cardiovascular

• No significant cardiovascular disease

Pulmonary

• No significant pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 weeks after study participation
• No significant rheumatologic disease
• No significant allergic disease
• No significant endocrine disease
• Human anti-mouse antibody negative
• HIV negative

Expected Enrollment

A total of 18 patients will be accrued for this study.

Outcomes

Toxicity and maximum tolerated dose every month during study treatment then every month for 6 months after completion of study treatment

Response rate every month during study treatment then every month for 6 months after completion of study treatment

Outline

This is a dose-escalation, multicenter study.

Patients receive monoclonal antibody HeFi-1 IV over 30-120 minutes on days 0, 3, 6, and 9. Treatment repeats every 28 days for up to 2 courses in the absence of unacceptable toxicity, a human mouse antibody concentration more than 250 ng/mL, or disease progression.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 month, every 3 months for 1 year, and then every 6 months thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

John Janik, MD, Protocol chair		Ph: 301-402-2913 Email: janikj@mail.nih.gov

Registry Information
Official Title		Phase I Study Of HeFi-1 In Refractory CD30-Positive Malignancy
Trial Start Date		2002-11-15
Trial Completion Date		2008-05-31 (estimated)
Registered in ClinicalTrials.gov		NCT00048880
Date Submitted to PDQ		2002-11-15
Information Last Verified		2009-03-10