Phase 2
Completed N=20
Cyclophosphamide, Fludarabine, and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
Melanoma (Skin)
Source: ClinicalTrials.gov NCT00085423 ↗
Enrolled (actual)
20
Serious AEs
44.4%
Results posted
Apr 2013
Primary outcomePrimary: Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST — 3 participants
Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST |
3 | — |
| SECONDARY Number of Participants With Lymphocyte Recovery as Measured by Blood Count |
18 | — |
| SECONDARY Time to Progression as Measured by RECIST |
.3 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed melanoma
- Metastatic disease
- Measurable disease
- No history of brain metastases
- Over 18
- Karnofsky 60-100%
- Life expectancy At least 12 weeks
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8.5 g/dL
- aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)
- Hepatitis B and C negative
- Creatinine ≤ 2.0 times ULN
- Creatinine clearance ≥ 50 mL/min
- Cardiovascular
- Ejection fraction ≥ 50%
- No evidence of congestive heart failure
- No symptoms of coronary artery disease
- No serious cardiac arrhythmias
- No myocardial infarction within the past 6 months
- Cardiac stress test negative or of low probability for patients > 40 years of age OR who have had prior myocardial infarction > 6 months ago
- Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age
- Diffusing capacity of lung for carbon monoxide ≥ 60%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
Exclusion Criteria
- No uncontrolled diabetes
- No history of autoimmune disease
- No active infection
- No other concurrent significant illness that would preclude study participation
- No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast)
- At least 4 weeks since prior immunotherapy and recovered
- No other concurrent anticancer biologic agents
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- At least 4 weeks since prior steroid therapy
- No concurrent corticosteroids
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 4 weeks since prior surgery and recovered
- No concurrent immunosuppressive therapy
Data sourced from ClinicalTrials.gov (NCT00085423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.