MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma

NCT00059995 | Completed Phase 1

• 3 other identifiers: MDX-060-01MSKCC-02121CDR0000298995
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma; anaplastic large cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent childhood large cell lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma

Interventions

iratumumab BIOLOGICAL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed B-cell or T-cell lymphoma * Hodgkin's lymphoma and anaplastic large cell lymphoma eligible * No HIV-associated lymphoma * CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry * At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30 * Must meet one of the following criteria for relapsed/refractory disease: * Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) * Relapsed disease must be within the prior irradiated field * Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option * Disease progression must be within the prior irradiated field * Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined) PATIENT CHARACTERISTICS: Age * Over 12 Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * WBC at least 1,500/mm\^3\* * Neutrophil count at least 1,000/mm\^3\* * Platelet count at least 75,000/mm\^3\* * Hemoglobin at least 8.0 g/dL\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Hepatic * AST no greater than 2 times upper limit of normal (ULN)\* * Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)\* * Hepatitis B surface antigen negative * Hepatitis C antibody negative NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Renal * Creatinine no greater than 2 times ULN\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 9 months after study participation * HIV negative * No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No active significant infection * No apparent opportunistic infection, as indicated by any of the following: * Purified protein derivative recently determined to be positive * Infectious infiltrate by chest x-ray * Recent changes in fever/chill patterns * New, unexplained neurological symptoms * No underlying medical condition that would preclude receiving study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior anti-CD30 antibody therapy * No other concurrent biologic therapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * No concurrent systemic steroidal therapy (excluding physiologic doses) Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No other concurrent investigational agents

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (1)

• Ansell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, Keler T, Graziano R, Blanset D, Yellin M, Fischkoff S, Assad A, Borchmann P. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol. 2007 Jul 1;25(19):2764-9. doi: 10.1200/JCO.2006.07.8972. Epub 2007 May 21.

  PMID: 17515574 RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Recurrence; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, T-Cell, Cutaneous

Interventions

iratumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Histiocytic Disorders, Malignant; Histiocytosis

Study Officials

• Steven M. Horwitz, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: January 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2009
• Last Updated: May 30, 2013

Record last verified: 2009-11

Locations

US (3)