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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iratumumab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
May 29, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059995
Brief Title
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
iratumumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Horwitz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17515574
Citation
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.
Results Reference
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MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma

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