Non Hodgkin Lymphoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00059995

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00059995

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider