## Protocol Section
### Identification Module
**NCT ID:** NCT00085579

**Brief Title:** Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

**Official Title:** A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy

#### Organization Study ID Info
**ID:** 04-027
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
#### Secondary ID Infos
**ID:** MSKCC-04027
### Status Module
#### Completion Date
**Date:** 2005-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-12-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-12-11

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2005-03

**Type:** ACTUAL

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2012-12

#### Study First Post Date
**Date:** 2004-06-11
**Type:** ESTIMATED
**Study First Submit Date:** 2004-06-10
**Study First Submit QC Date:** 2004-06-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Memorial Sloan Kettering Cancer Center

### Description Module

**Brief Summary:** RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.

**Detailed Description:** OBJECTIVES:

Primary

* Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF).

Secondary

* Determine the time to progression in patients treated with this regimen.
* Determine the effects of this regimen on lymphocyte subsets in these patients.

OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease \[SD\] vs partial response \[PR\]).

Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2\* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12.

NOTE: \*Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration

Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course.

PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.

### Conditions Module

**Conditions:**

- Melanoma (Skin)

**Keywords:**

- stage III melanoma

- stage IV melanoma

### Design Module

#### Design Info

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** aldesleukin

**Type:** BIOLOGICAL

#### Intervention 2

**Name:** sargramostim

**Type:** BIOLOGICAL

#### Intervention 3

**Name:** adjuvant therapy

**Type:** PROCEDURE

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma

  * Stage III or IV disease
  * No primary ocular melanoma
* Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago

  * Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible
  * Patients whose second evaluation shows disease progression are eligible unless one of the following is true:

    * Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN)
    * LDH \> ULN AND is higher than the patient's highest value before systemic chemotherapy
    * Patient has developed a new tumor measuring \> 1 cm in diameter
    * Sum of the longest diameters of the existing tumor has increased \> 20%
* Evaluable or measurable disease
* Not potentially curable by surgery
* No active CNS metastases

  * Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry

PATIENT CHARACTERISTICS:

Age

* 16 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No active bleeding

Hepatic

* See Disease Characteristics
* Bilirubin ≤ 2.0 mg/dL

Renal

* Creatinine ≤ 1.2 mg/dL

Cardiovascular

* Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:

  * Normal exercise stress test
  * Normal stress thallium test
  * Normal comparable cardiac ischemia evaluation
* LVEF ≥ 40%

Other

* No active infection requiring treatment
* No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No other concurrent antineoplastic biologic response modifier therapy
* No concurrent antineoplastic vaccine therapy

Chemotherapy

* See Disease Characteristics
* No concurrent antineoplastic chemotherapy

Endocrine therapy

* No concurrent steroidal antiemetics
* No concurrent systemic corticosteroids

Radiotherapy

* See Disease Characteristics
* No concurrent antineoplastic radiotherapy

Surgery

* See Disease Characteristics
* Recovered from prior surgery
* Surgery within the past 4 weeks allowed provided there is no evidence of disease progression

Other

* More than 4 weeks since prior therapy for melanoma
* No other concurrent antineoplastic experimental therapy

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Memorial Sloan-Kettering Cancer Center

**State:** New York

**Zip:** 10021

#### Overall Officials

**Official 1:**

**Affiliation:** Memorial Sloan Kettering Cancer Center

**Name:** Paul B. Chapman, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Memorial Sloan Kettering Cancer Center

**Name:** Jedd D. Wolchok, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000018326

- Term: Nevi and Melanomas

- ID: D000012878

- Term: Skin Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11528

- Name: Melanoma

- Relevance: HIGH

- As Found: Melanoma

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12448

- Name: Nevus, Pigmented

- Relevance: LOW

- As Found: Unknown

- ID: M12446

- Name: Nevus

- Relevance: LOW

- As Found: Unknown

- ID: M20470

- Name: Nevi and Melanomas

- Relevance: LOW

- As Found: Unknown

- ID: M15681

- Name: Skin Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008545

- Term: Melanoma

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M225496

- Name: Aldesleukin

- Relevance: HIGH

- As Found: Platinum

- ID: M257633

- Name: Molgramostim

- Relevance: LOW

- As Found: Unknown

- ID: M219218

- Name: Sargramostim

- Relevance: HIGH

- As Found: Irradiation

- ID: M10411

- Name: Interleukin-2

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000082598

- Term: Aldesleukin

- ID: C000081222

- Term: Sargramostim

### Misc Info Module

- Version Holder: 2024-05-24
