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

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00039091
• Other study ID #: NCI-2012-03144
• Secondary ID: 01-228R21CA10577
• Status: Terminated
• Phase: Phase 1
• Start date: March 2002
• Est. completion date: November 21, 2007

Study information

• Verified date: September 2018
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 21, 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Carcinoma, Non-Small-Cell Lung
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
• Lung Neoplasms
• Melanoma
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
• Myeloproliferative Disorders
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Preleukemia
• 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
• Syndrome

Intervention

Biological:
• ipilimumab
Given IV

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0		Up to 6 years
Secondary	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.	Up to 6 years
Secondary	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.	Up to 2 months post-treatment