Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma

NCT00055783 | Completed Phase 2

• 2 other identifiers: SUMC-NCI-1951CDR0000271198
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies 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 monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Interventions

apolizumab BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * Progressive or recurrent disease after standard initial therapy * At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques) * Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation * Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No known human anti-human antibody * No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10 * No ongoing or active infection * No other uncontrolled concurrent illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Chemotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies

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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

apolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sandra J. Horning, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: July 1, 2002
• Study Completion: April 1, 2003
• Last Updated: May 15, 2013

Record last verified: 2003-04

Locations

US (1)