Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer

Overseen by Nageshwara V Dasari

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the best dose and side effects of talimogene laherparepvec in combination with 5-fluorouracil, leucovorin, oxaliplatin, capecitabine, and chemoradiation before surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue and lymph nodes. Drugs used in immunotherapy, such as talimogene laherparepvec, may stimulate the body's immune system to fight tumor cells. Drugs used in chemotherapy, such as 5-fluorouracil, leucovorin, oxaliplatin, and capecitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving talimogene laherparepvec, 5-fluorouracil, leucovorin, oxaliplatin, and capecitabine and chemoradiation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Research Team

Nageshwara V Dasari

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

Inclusion Criteria

You must be at least 18 years old to participate in the study.

Your hemoglobin levels need to be at least 9 grams per deciliter.

Your platelet count is equal to or greater than 100,000 per microliter of blood.

Exclusion Criteria

Evidence of clinically significant immunosuppression

Pregnant or breastfeeding, planning to become pregnant during study treatment and through 4 months after last dose of talimogene laherparepvec, unwilling to use acceptable method(s) of effective contraception

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of therapy or anticipation of need for major surgical procedure during study

Treatment Details

Interventions

• Capecitabine (Chemotherapy)
• Fluorouracil (Chemotherapy)
• Leucovorin (Chemotherapy)
• Oxaliplatin (Chemotherapy)
• Radiation Therapy (Radiation)
• Talimogene Laherparepvec (Virus Therapy)

Participant Groups

Group I: Treatment (T-VEC, capecitabine, chemoradiation) Experimental Treatment 6 Interventions

Patients receive talimogene laherparepvec intralesionally via endoscopy on weeks 1, 4, 6, and 8. Patients receive 5-fluorouracil IV by bolus and over 46 hours, leucovorin IV bolus, and oxaliplatin IV over 2 hours on weeks 2 and 4. Patients also receive capecitabine orally PO BID followed by radiation therapy for 28 fractions on days 1-5 of weeks 8-13. Patients undergo resection surgery on weeks 21-25.

Capecitabine is already approved in Canada, Japan for the following indications:

Approved in Canada as Xeloda for:

• Colorectal cancer
• Breast cancer

Approved in Japan as Xeloda for:

• Colorectal cancer
• Breast cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School