Trial Outcomes & Findings for Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma (NCT NCT00863330)

Results Overview

Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

4-6 weeks after completion of TIL

Results posted on

2024-10-03

Participant Flow

14 participants were enrolled. For those, 8 were screen failures and 6 started the study.

Participant milestones

Participant milestones
Measure	Determine Toxicity of Treatment Regimen. Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Determine Toxicity of Treatment Regimen. Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Overall Study study terminated early due to administra	6

Baseline Characteristics

Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Determine Toxicity of Treatment Regimen. n=6 Participants Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Age, Customized 18 or over	6 participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks after completion of TIL

Population: Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed

Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.

Outcome measures

Outcome data not reported

Adverse Events

Determine Toxicity of Treatment Regimen.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

IIR regulatory specialist

Aurora Health Care

Phone: 414-219-7886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place