Lung Cancer Trials Ask AI to find trials
TerminatedPhase 1NCT00039091
Official study title

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

Study 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

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedipilimumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 5, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Biological: ipilimumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Treatment approach
Immunotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 5, 2018. Always confirm current availability with the study team.

View original record ↗