Clinical trial · Interventional
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk 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)
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use 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 melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| interferon alfa | Biological | — | UNRESOLVED |
| interleukin-2 | Biological | Aldesleukin | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: interferon alfa
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: interleukin-2
- Biological: filgrastim
- Biological: interferon alfa
- Drug: cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence
* No distant metastases
* No melanoma of ocular, mucosal, or other non-cutaneous origin
* One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:
* Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or macro/clinically overt)
* Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
* No non-ulcerated or unknown primary tumor and a single micrometastatic lymph node
* Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or macro/clinically overt) and/or matted nodes
* Any satellite/in transit metastasis with or without lymph node involvement
* Patients with recurrent disease must have recurrent disease in the regional nodal basin of a prior complete lymphadenectomy
* Multiple regional nodal basin involvement allowed if they are appropriate anatomic drainage basins for primary site
* Patients must be disease free at time of enrollment based on the following surgical criteria:
* Patients at initial presentation of melanoma must undergo adequate wide excision of primary lesion
* Patients with previously diagnosed melanoma must have all disease resected with pathologically negative margins and no disease at primary site or second resection of primary
* Full lymphadenectomy required of all patients including those with positive sentinel nodes or positive satellite/in-transit metastasis
* No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent disease after prior complete lymphadenectomy
* Must be willing to participate in minimal residual disease studies if registered on the study on 3/1/2003 or later
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2 times ULN
* LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires a contrast-enhanced CT scan or MRI of liver)
* No known recent hepatitis positivity by PCR
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 75 mL/min
Cardiovascular:
* No congestive heart failure
* No coronary artery disease
* No serious cardiac arrhythmia
* No prior myocardial infarction
* Normal cardiac stress test required if any of the following are present:
* Over age 50
* Abnormal EKG
* History of cardiac disease
Pulmonary:
* No symptomatic pulmonary disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No autoimmune disorders or conditions of immunosuppression
* No other prior malignancy within the past 5 years except the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer in remission
* HIV negative
* No known AIDS or HIV-1 associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy, including interferon, interleukin, levamisole, or other biologic response modifiers
* No other concurrent biologic therapy
Chemotherapy:
* No prior chemotherapy (including infusion or perfusion therapy)
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent systemic corticosteroids or topical steroid creams
* Concurrent steroid antihistamines allowed if no alternative
* No concurrent hormonal therapy
Radiotherapy:
* No prior radiotherapy
* Prior postlumpectomy radiotherapy for breast cancer allowed
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* No concurrent surgery
Other:
* No concurrent anti-hypertensive medications (arm II only)
* No concurrent immunosuppressive agents
* No other concurrent anticancer therapy
* Antihistamines allowed if no alternative medication suitableReferences
Publications (1)
- DERIVEDFlaherty LE, Othus M, Atkins MB, Tuthill RJ, Thompson JA, Vetto JT, Haluska FG, Pappo AS, Sosman JA, Redman BG, Moon J, Ribas A, Kirkwood JM, Sondak VK. Southwest Oncology Group S0008: a phase III trial of high-dose interferon Alfa-2b versus cisplatin, vinblastine, and dacarbazine, plus interleukin-2 and interferon in patients with high-risk melanoma--an intergroup study of cancer and leukemia Group B, Children's Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group. J Clin Oncol. 2014 Nov 20;32(33):3771-8. doi: 10.1200/JCO.2013.53.1590. Epub 2014 Oct 20. PMID 25332243