- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00039091
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
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 Overview
Status
Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Previously Treated Myelodysplastic Syndromes
- Recurrent Melanoma
- Stage IV Melanoma
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Recurrent Ovarian Epithelial Cancer
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (ipilimumab)
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.
|
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame: Up to 6 years
|
Up to 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Up to 6 years
|
90% confidence intervals will be estimated.
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Up to 6 years
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Proportion of patients who mount a brisk immune response, graded as absent, non-brisk, and brisk as described by Mihm
Time Frame: Up to 2 months post-treatment
|
90% confidence intervals will be estimated.
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Up to 2 months post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Hodi, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Disease
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Precancerous Conditions
- Neuroendocrine Tumors
- Nevi and Melanomas
- Ovarian Neoplasms
- Syndrome
- Myelodysplastic Syndromes
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Recurrence
- Preleukemia
- Melanoma
- Carcinoma, Ovarian Epithelial
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Antibodies
- Immunoglobulins
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Ipilimumab
Other Study ID Numbers
- NCI-2012-03144
- 01-228
- R21CA105776 (U.S. NIH Grant/Contract)
- CDR0000069349 (Registry Identifier: PDQ (Physician Data Query))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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