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Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

Primary Purpose

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ipilimumab
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility Criteria

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

Inclusion Criteria: Patients previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia, or non-small cell lung cancer cells; patients with acute myelogenous leukemia/myelodysplasia or non-small cell lung cancer who have not been vaccinated with an autologous, GM-CSF based vaccine >= 4 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy) Patients must have recovered from any acute toxicity associated with prior therapy Measurable epithelial ovarian cancer, melanoma, AML/MDS, or non-small cell lung cancer No standard curative treatment options Not require immediate palliative therapy Patients with epithelial ovarian cancer must have persistent or recurrent disease following primary surgery and primary chemotherapy Patients with melanoma must be stage IV disease Patients with AML/MDS, but without MDS, must be: a) in second relapse or b) first relapse with no option for bone marrow transplant or c) not a candidate for immunosuppressive chemotherapy due to age or comorbid disease Patients with non-small cell lung cancer must be not curable by standard surgery, chemotherapy, and/or radiation Life expectancy >= 12 weeks ECOG performance status of 0, 1 or 2 Written informed consent Due to the unknown effects of MDX-CTLA-4 on the fetus or nursing infant, pregnant or nursing women should not be included; women should be either: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing an intrauterine device, and/or spermicide and barrier, for contraception; during the study, use of oral contraception alone is not acceptable; women of childbearing potential must have a negative serum beta-HCG pregnancy test conducted during screening, and a negative urinary beta-HCG pregnancy test conducted within 24 hours prior to treatment; due to the unknown effects of MDX-CTLA-4 on the fetus, men should not father children during the study WBC > 1,000 cells/mm^3 (except for AML/MDS patients) Serum creatinine < 2 mg/dL Platelets > 75,000 cells/mm^3 (except for AML/MDS patients) AST and ALT < 2 x UNL Total bilirubin < 2 x UNL Exclusion Criteria: Active infection Autoimmune disease requiring immunosuppressive treatment Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events Any concurrent medical condition requiring the use of systemic steroids (use of inhaled or topical steroids is acceptable) CNS metastases, unless previously treated and stable for at least three months Patients who have received prior treatment with MDX-CTLA-4

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ipilimumab)

Arm Description

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

Secondary Outcome Measures

Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)
90% confidence intervals will be estimated.
Proportion of patients who mount a brisk immune response, graded as absent, non-brisk, and brisk as described by Mihm
90% confidence intervals will be estimated.

Full Information

First Posted
June 6, 2002
Last Updated
September 4, 2018
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039091
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Official Title
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC# 732442, Previously 720801) in Patients Previously Vaccinated With GM-CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients With Acute Myelogenous Leukemia/ Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received a Prior Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Study Start Date
March 2002 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 21, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety of MDX-CTLA-4 in patients previously and not previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia or lung cancer cells. II. To identify preliminary evidence of biologic activity and efficacy. OUTLINE: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity. Patients are followed monthly until disease progression. PROJECTED ACCRUAL: A total of 48 patients (12 per disease type; 36 previously treated with a sargramostim (GM-CSF)-expressing autologous tumor cell vaccine and 12 not previously treated with this vaccine) 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
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Melanoma, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Melanoma, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ipilimumab)
Arm Type
Experimental
Arm Description
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
ipilimumab
Other Intervention Name(s)
anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Description
90% confidence intervals will be estimated.
Time Frame
Up to 6 years
Title
Proportion of patients who mount a brisk immune response, graded as absent, non-brisk, and brisk as described by Mihm
Description
90% confidence intervals will be estimated.
Time Frame
Up to 2 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia, or non-small cell lung cancer cells; patients with acute myelogenous leukemia/myelodysplasia or non-small cell lung cancer who have not been vaccinated with an autologous, GM-CSF based vaccine >= 4 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy) Patients must have recovered from any acute toxicity associated with prior therapy Measurable epithelial ovarian cancer, melanoma, AML/MDS, or non-small cell lung cancer No standard curative treatment options Not require immediate palliative therapy Patients with epithelial ovarian cancer must have persistent or recurrent disease following primary surgery and primary chemotherapy Patients with melanoma must be stage IV disease Patients with AML/MDS, but without MDS, must be: a) in second relapse or b) first relapse with no option for bone marrow transplant or c) not a candidate for immunosuppressive chemotherapy due to age or comorbid disease Patients with non-small cell lung cancer must be not curable by standard surgery, chemotherapy, and/or radiation Life expectancy >= 12 weeks ECOG performance status of 0, 1 or 2 Written informed consent Due to the unknown effects of MDX-CTLA-4 on the fetus or nursing infant, pregnant or nursing women should not be included; women should be either: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing an intrauterine device, and/or spermicide and barrier, for contraception; during the study, use of oral contraception alone is not acceptable; women of childbearing potential must have a negative serum beta-HCG pregnancy test conducted during screening, and a negative urinary beta-HCG pregnancy test conducted within 24 hours prior to treatment; due to the unknown effects of MDX-CTLA-4 on the fetus, men should not father children during the study WBC > 1,000 cells/mm^3 (except for AML/MDS patients) Serum creatinine < 2 mg/dL Platelets > 75,000 cells/mm^3 (except for AML/MDS patients) AST and ALT < 2 x UNL Total bilirubin < 2 x UNL Exclusion Criteria: Active infection Autoimmune disease requiring immunosuppressive treatment Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events Any concurrent medical condition requiring the use of systemic steroids (use of inhaled or topical steroids is acceptable) CNS metastases, unless previously treated and stable for at least three months Patients who have received prior treatment with MDX-CTLA-4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hodi
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

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