Clinical trial · Interventional
High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Melanoma
Phase II Trial of High Dose Interleukin-2 Followed by Intermittent Low Dose Temozolomide in Patients With Metastatic Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators have observed that many patients who had received high dose Interleukin-2 (IL2) and failed to respond to it but who then go immediately to temozolomide seemed to enjoy extremely good responses which seem better quality and longer duration than typically observed for temozolomide alone. To date, the investigators have observed 5 sequentially treated patients with metastatic melanoma who had failed high dose IL-2 but who then went on to receive immediate temozolomide. Two of these patients had complete responses and 3 had very strong partial response. In a recent phase II study of extended low dose temozolomide alone given in the same manner as the post IL-2 patients noted above, the response rate was 12.5% and all of these were partial responses only. The responses that the investigators observed were at a much higher rate of response as well as much better quality than expected for temozolomide. The responses were also better than those observed when temozolomide was given first and then followed by high dose IL-2. The investigators concluded that perhaps the major benefit the investigators observed was a result of the prior high dose IL-2 therapy modulated by the temozolomide and that the sequence of treatment was clearly crucial for this response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Course 1 Cycle 1 and Cycle 2
- description
- Course 1 Cycle 1: Participants will be given high-dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. Course 1 Cycle 2: Participants will be given high-dose Interleukin-2 (HD IL-2) 600,000 IU/kg, up to 14 doses at 8 hour intervals. On the day after discharge, patients will be given oral temozolomide at 75 mg/m2 daily for 21 days.
- interventionNames
- Drug: Interleukin-2
- Drug: Temozolomide
Primary outcomes (3)
- measure
- Clinical Response to High-Dose Interleukin-2 (H-D IL-2) Followed by Low Dose Temozolomide
- timeFrame
- 2 years
- description
- Clinical response was measured using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria categorizing responses as complete response (CR), partial response (PR), minor response (MR), stable disease (SD), or progressive disease (PD).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed metastatic malignant melanoma * Age \> 18 years * Eastern Cooperative Oncology Group performance status of 0 or 1 * Patients considered good candidate for conventional high dose IL-2 * No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of entry * Patients with a history or clinical evidence of brain metastasis must have completed radiation therapy or surgical treatment of brain lesions and have no evidence of central nervous system progression for at least 8 weeks at the time of enrollment. * Patients may have had prior high dose IL-2 or temozolomide but not together or with high dose IL-2 followed by temozolomide * Patients may have had prior high dose interferon as adjuvant treatment for high risk melanoma * Serum creatinine \< 2 mg/dL * Bilirubin \< 2 mg/dL Exclusion Criteria: * Inability to provide informed consent * Hypersensitivity to temozolomide or HD IL-2 * Active gastrointestinal disorder or cardiac disorders * Ejection fraction \< 50% by echocardiogram or corrected diffusing capacity of lung for carbon monoxide \< 50% on diffusion capacity testing pulmonary function tests * platelets \< 100 K, neutrophils \< 1000 * Serum Creatinine \< 2 x the upper limits of normal * Chronic use of steroids other than for simple adrenal replacement
References
Publications (0)
Data not yet available