NCT00003741

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 I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 26, 2013

Status Verified

March 1, 2005

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomaanaplastic large cell lymphoma

Interventions

monoclonal antibody HeFi-1BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma * At least 50% of malignant cells must react with HeFi-1 * HIV positive or HIV negative * Measurable disease * No symptomatic CNS disease * Must have failed or be ineligible for standard chemotherapy regimen PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * More than 2 months Hematopoietic: * Not specified Hepatic: * No significant hepatic disease * Bilirubin no greater than 2 mg/dL Renal: * No significant renal disease * Creatinine no greater than 3 mg/dL Cardiovascular: * No significant cardiovascular disease Pulmonary: * No significant pulmonary disease Other: * No significant endocrine, rheumatologic, or allergic disease * No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine antibody therapy Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy to measurable disease Surgery: * Not specified Other * At least 4 weeks since prior cytotoxic therapy to measurable disease

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

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Study Officials

  • Henry Koon, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

February 1, 1999

Study Completion

December 1, 2007

Last Updated

June 26, 2013

Record last verified: 2005-03

Locations

US(1)