Genetically Modified T-Cells + Aldesleukin for Melanoma

Overseen By Rodabe N. Amaria, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot phase I trial studies the side effects and best dose of genetically modified T-cells followed by aldesleukin in treating patients with stage III-IV melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory. Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells.

Research Team

Rodabe N. Amaria

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with stage III-IV melanoma who have adequate lung function, no severe psychiatric diseases, and are not pregnant or nursing. Participants must not have had recent cancer treatments, organ transplants, significant medical illnesses, or be on chronic steroids. They need measurable melanoma lesions suitable for T-cell generation and agree to use birth control.

Inclusion Criteria

I have been active and mostly self-sufficient in the last month.

I had a brain scan within the last 30 days.

My melanoma has spread or is in stage III.

Exclusion Criteria

Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent

I haven't had cancer treatment or specific inhibitors in the last 4 weeks/7 days.

Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Patients receive cyclophosphamide and fludarabine phosphate intravenously to prepare for T-cell infusion

1 week

Daily visits for 5 days

T-Cell Infusion and Aldesleukin Treatment

Patients receive TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes followed by high-dose aldesleukin

5 days

Inpatient stay for monitoring and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at 6 and 12 weeks, then every 3 months for 1 year, and yearly for 10 years

Treatment Details

Interventions

• Aldesleukin
• NGFR-transduced Autologous T Lymphocytes

Trial Overview The trial tests genetically modified T-cells designed to target melanoma followed by aldesleukin (a substance that can boost the immune system). It aims to find the best dose and observe side effects. The process involves modifying patients' own T-cells in a lab before reintroducing them into their bodies.

Participant Groups

Group I: Treatment (chemotherapy, autologous T-cell immunotherapy) Experimental Treatment 6 Interventions

Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+