Monoclonal Antibody Therapy in Treating Patients With Leukemia

NCT00019227 | Completed Phase 1

• 2 other identifiers: CDR0000065240NCI-96-C-0147K
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.

Conditions

Lymphoma; Radiation Toxicity

Keywords

stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; recurrent adult T-cell leukemia/lymphoma; radiation toxicity

Interventions

pentetic acid calcium DRUG

yttrium Y 90 daclizumab RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage * Tac expression of malignant cells confirmed by one of the following: * At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining * Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL) * Measurable disease required * More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease * All stages of Tac-expressing adult T-cell leukemia are eligible * Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat * Smoldering ATL, defined as: * Lymphocyte count less than 4,000/mm\^3 * Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood * No hypercalcemia * Lactate dehydrogenase no greater than 1.5 times normal * No lymphadenopathy * No involvement of extranodal organs except skin or lung * No malignant pleural effusion or ascites * No symptomatic CNS disease due to ATL * Concurrent diagnosis of tropical spastic paraparesis allowed * No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Greater than 2 months Hematopoietic: * Absolute granulocyte count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL (unless directly due to ATL) * AST/ALT less than 2.5 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 35 mL/min Cardiovascular: * No clinical cardiac failure Pulmonary: * No symptomatic pulmonary dysfunction unless due to underlying malignancy Other: * HIV negative * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy * Concurrent corticosteroids allowed Radiotherapy * Not specified Surgery * Not specified Other * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Lymphoma; Radiation Injuries; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Pentetic Acid; Daclizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Wounds and Injuries; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas A. Waldmann, MD

  NCI - Metabolism Branch;MET

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 1996
• Study Completion: July 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2003-03

Locations

US (1)