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

Lymphoma Clinical Trial

Official title:

Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059995
• Other study ID #: MDX-060-01
• Secondary ID: MSKCC-02121CDR00
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 6, 2003
• Last updated: May 29, 2013
• Start date: January 2003
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.

• Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.

• Determine the pharmacokinetic profile of this drug in these patients.

• Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.

Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• iratumumab

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation