Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma

Summary

This phase II trial studies how well autologous tumor infiltrating lymphocytes MDA-TIL works in treating patients with ovarian cancer, colorectal cancer, or pancreatic ductal adenocarcinoma that has come back (recurrent) or does not respond to treatment (refractory). Autologous tumor infiltrating lymphocytes MDA-TIL, made by collecting and growing specialized white blood cells (called T-cells) from a patient's tumor, may help to stimulate the immune system in different ways to stop tumor cells from growing.

Conditions

• Malignant Solid Neoplasm
• Metastatic Colorectal Adenocarcinoma
• Metastatic Ovarian Carcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma
• Platinum-Resistant Ovarian Carcinoma
• Recurrent High Grade Ovarian Serous Adenocarcinoma
• Recurrent Ovarian Carcinosarcoma
• Refractory Colorectal Carcinoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Interventions

BIOLOGICAL

Autologous Tumor Infiltrating Lymphocytes MDA-TIL

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Interleukin-2

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Iovance Biotherapeutics

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Amir A Jazaeri · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-16

Primary Completion

2024-08-21

Completion

2024-08-21

FDA Drug

Yes

Countries

• United States

Study Locations