Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00338377 · ClinicalTrials.gov registry record · Phase 2

Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

A Phase 2 study of Melanoma, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 2
Development phase
1,230
Enrollment target
1
Study location

NCT00338377: Active Phase 2 study of Melanoma, sponsored by M.D. Anderson Cancer Center.

NCT00338377 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 1,230 participants, above the 702-participant average among 266 other Melanoma trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00338377, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
1,230 participants
Enrollment target
1
Study location

Study Summary

Objectives: The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 (Cohort A) have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone. Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site. In addition, we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo. Additionally, secondary objectives will include correlation of clinical parameters with survival (overall survival and progression-free survival) for all cohorts. COHORT C In a separate cohort (Cohort C) the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone. COHORT D The primary objective of Cohort D is to confirm the safety of adoptively transferred, TIL into the CSF. The secondary objective is the evaluation of clinical imaging and CSF response. Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF, assess circulating tumor cells in the CSF, and assess various cytokine and other analyses,as feasible. COHORT E The primary objective of Cohort E is to determine the overall response rate of TIL treatment with cells grown by the TIL 3.0 pre-REP (Turnstile 1) phase of cellular growth.

Primary Outcome

Objective response (OR) defined as immune-related Best Overall Response (irBOR). irBOR is best confirmed immune-related response criteria (irRC) overall response over the study as a whole, recorded between the date of first dose until the last tumor assessment before subsequent therapy (except for local palliative radiotherapy for painful bone lesions) for the individual subjects in the study.

Conditions Studied

Melanoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Interleukin-2
  • BIOLOGICAL Dendritic Cell Immunization
  • BIOLOGICAL T-Cells

Study Locations (1)

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 1,230 participants
Start Date 2006-02-01
Est. Completion 2030-02-28
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the registry record for NCT00338377 still lists

NCT00338377 is an interventional study that assigns participants to a tested intervention. Its 1,230 participants enrollment target places it among the larger protocols in the corpus, above the 702-participant average among 266 other Melanoma trials with a reported enrollment target (75% higher).

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00338377 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00338377 about?

NCT00338377 is a clinical study titled "Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma". Objectives: The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 (Cohort A) have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone. Secondary endpoints will include eval...

What is the current status of trial NCT00338377?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,230 participants. The study started on 2006-02-01. Estimated completion is 2030-02-28.

What conditions does trial NCT00338377 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT00338377?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Interleukin-2 (BIOLOGICAL), Dendritic Cell Immunization (BIOLOGICAL), T-Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT00338377?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00338377 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00338377's enrollment target sits among peer trials

1,230 15th of 266 higher than 252 of 266 other Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05946044 · 1,230 participants · NA

    The Osteoarthritis Prevention Study

  • NCT06787937 · 1,230 participants · NA

    Communicating About Nicotine Reduction in Cigarettes

  • NCT05456841 · 1,232 participants · NA

    Empathic Communication Skills (ECS) Training

  • NCT06921785 · 1,220 participants · Phase 3

    Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT00338377, the US trial registry maintained by the National Library of Medicine. NCT00338377 (large enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.