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Activated T-cell Therapy, Low-Dose Aldesleukin, and Sargramostim in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That is Stage III-IV, Refractory, or Recurrent

NCT02470559 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-02-17

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of activated T-cell therapy when given together with low-dose aldesleukin and sargramostim in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is stage III-IV, has not responded to previous treatment, or has come back. Activated T cells that have been coated with bi-specific antibodies, such as anti-cluster of differentiation (CD)3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Giving activated T-cell therapy with low-dose aldesleukin and sargramostim may be a better treatment for ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

  • Malignant Ovarian Clear Cell Tumor
  • Malignant Ovarian Serous Tumor
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Primary Peritoneal Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer

Interventions

BIOLOGICAL

Aldesleukin

Given SC

BIOLOGICAL

HER2Bi-Armed Activated T Cells

Given IV and IP

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Sargramostim

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Lawrence Lum · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-02-28
Completion
2017-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470559 on ClinicalTrials.gov