Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00539591 · ClinicalTrials.gov registry record · Phase 2
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
A Phase 2 study of Malignant Melanoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 3
- Study locations
NCT00539591: Active Phase 2 study of Malignant Melanoma, sponsored by St. Jude Children's Research Hospital.
NCT00539591 is a Phase 2 study of Malignant Melanoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 29 participants, below the 182-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00539591, a Phase 2 study of Malignant Melanoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main goal of this study is to estimate the tumor response rate of temozolomide administered in combination with peginterferon alfa-2b to pediatric patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.
Primary Outcome
Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease meas
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Peginterferon alfa-2b
- DRUG Recombinant interferon alfa-2b
Study Locations (3)
California
- Rady Children's Hospital - San Diego
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- The Children's Cancer Hospital at UT M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-05-09 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What the registry record for NCT00539591 still lists
NCT00539591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 182-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT00539591 reports a single indexed study location in California, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT00539591 about?
NCT00539591 is a clinical study titled "Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma". The main goal of this study is to estimate the tumor response rate of temozolomide administered in combination with peginterferon alfa-2b to pediatric patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.
What is the current status of trial NCT00539591?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2008-05-09. Estimated completion is 2026-05.
What conditions does trial NCT00539591 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT00539591?
The interventions under investigation include: Temozolomide (DRUG), Peginterferon alfa-2b (DRUG), Recombinant interferon alfa-2b (DRUG).
Who is sponsoring clinical trial NCT00539591?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00539591 being conducted?
This trial has 3 study locations across California, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant 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 NCT00539591's enrollment target sits among peer trials
29 20th of 28 higher than 9 of 28 other Malignant Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant 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
-
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
RECRUITING · Phase 2
-
A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
COMPLETED · Phase 2
-
Phase II Trial of Allovectin-7® for Metastatic Melanoma
COMPLETED · Phase 2
-
GM-CSF as Adjuvant Therapy of Melanoma
COMPLETED · Phase 2
-
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
RECRUITING
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
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
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
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