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

Alternate Title

Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Supportive care, Treatment Active 18 and over NCI NCI-97-C-0110Q NCT00019305

Special Category: NIH Clinical Center trial

Objectives

1. Assess the toxicity and therapeutic efficacy of yttrium Y 90 radiolabeled humanized anti-Tac (HAT) monoclonal antibody in patients with Tac expressing hematologic malignancies.
2. Define the pharmacokinetics of indium In 111 and yttrium Y 90 HAT monoclonal antibodies.

Entry Criteria

Disease Characteristics:

• Histologically confirmed Hodgkin's lymphoma, non-Hodgkin's lymphoma, or lymphoid leukemia with at least 10% of malignant cells reacting with anti-Tac monoclonal antibody (waived for Hodgkin's lymphoma)



• Must meet the following disease specific criteria:
  • Non-Hodgkin's lymphoma (NHL)
    • Indolent stages II-IV that failed at least one standard therapy and requiring treatment
    • Aggressive NHL that relapsed after standard chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
  • Hodgkin's lymphoma
    • Stages II-IV that relapsed or failed to achieve complete remission after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
  • Cutaneous T-cell lymphoma
    • Stages Ib-III that failed at least one standard therapy
    • Stage IV eligible regardless of prior therapy
  • Peripheral T-cell lymphoma
    • Stages I-IV that relapsed after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
  • Other lymphoid leukemia or lymphoma
    • Failed standard therapy and not eligible for or refused salvage chemotherapy or bone marrow transplantation

Prior/Concurrent Therapy:

Biologic therapy:

• No chronic anticoagulant therapy
• No prior bone marrow or stem cell transplantation

Chemotherapy:

• At least 3 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• Corticosteroids allowed if dose is stable for at least 3 weeks

Radiotherapy:

• At least 3 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 50-100%

Life expectancy:

• Greater than 1 month

Hematopoietic:

• Granulocyte count at least 1,200/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• SGOT and SGPT less than 5 times upper limit of normal (ULN)
• Bilirubin less than 3 times ULN

Renal:

• Creatinine less than 2.0 mg/dL

  OR

• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• No clinical evidence of cardiac failure

Pulmonary:

• No symptomatic pulmonary dysfunction unless due to malignancy

Other:

• Not pregnant or nursing
• Negative pregnancy test
• HIV negative
• No active second primary malignancy other than basal cell skin cancer
• No symptomatic disease due to CNS involvement

Expected Enrollment

Approximately 55 patients will be accrued in phase I and an additional 30 patients in phase II.

Outcomes

Response rate after completion of treatment

Survival at 2 years

Outline

This is a dose escalation study.

Patients are given yttrium Y 90 labeled humanized anti-Tac monoclonal antibody (Y-HAT) according to an escalating dose schedule along with a fixed dose of pentetic acid calcium (Ca-DTPA) and indium In 111 labeled humanized anti-Tac monoclonal antibody (In-HAT). On day 1, Y-HAT and In-HAT are administered IV over 2 hours followed by a 5 hour infusion of Ca-DTPA. Additional 5 hour infusions of Ca-DTPA are given on days 2 and 3. On day 42 the treatment course may be repeated at the same dosage level.

Cohorts of 3 to 6 patients are enrolled at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. After the MTD is defined the phase II portion of the study begins.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Thomas Waldmann, MD, Protocol chair		Ph: 301-496-6656 Email: tawald@helix.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Registry Information
Official Title		Phase I/II of Tac-Expressing Malignancies [Other Than ATL] with Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA
Trial Start Date		1997-04-23
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00019305
Date Submitted to PDQ		1997-06-15
Information Last Verified		2008-04-06