Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma

NCT01005472 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000634373UCLA-0711052SPRI-P05513PFIZER-GA6181FZ10-001406
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells. Phase II was never conducted due to toxicity in phase I. PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.

Conditions

Metastatic Melanoma

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; metastatic intraocular melanoma; recurrent intraocular melanoma

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)

  6 weeks

• Overall safety

  5 years

• Response rate as assessed by modified RECIST criteria (phase II)

  Phase II was never conducted due to toxicity in phase I.

  5 years

Secondary Outcomes (3)

• Response rate as assessed by modified RECIST criteria (Phase I)

  6 weeks

• Progression-free survival

  5 years

• Overall survival

  5 years

Study Arms (1)

sunitinib malate, temozolomide

EXPERIMENTAL

Drug: sunitinib malate; Drug: temozolomide

Interventions

sunitinib malate DRUG

sunitinib malate, temozolomide

temozolomide DRUG

sunitinib malate, temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
• ECOG performance status of 0-2
• age greater than or equal to 18 years
• ANC ≥ 1,500/µL
• Platelet count ≥ 100,000/µL
• Hemoglobin ≥ 10.0 g/dL
• Creatinine ≤ 2 times upper limit of normal (ULN)
• Total bilirubin ≤ 2 times ULN
• LDH ≤ 5 times ULN
• AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
• LVEF ≥ 50% on screening ECHO
• women of childbearing potential must have a negative urine or serum pregnancy test upto 28 days prior to commencement of dosing.
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• before study entry , written informed consent must be obtained. Written informed consent must be obtained from patient prior to performing any study related procedures.

You may not qualify if:

• pregnant or nursing
• any following within the past 12 months:
• Myocardial infarction
• Severe and/or unstable angina
• Coronary and/or peripheral artery bypass graft
• Symptomatic congestive heart failure
• Cerebrovascular accident or transient ischemic attack
• Pulmonary embolism
• ongoing cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
• prolonged QTc interval on baseline EKG
• uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg despite optimal medical therapy)
• pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• any known clinically uncontrolled infectious disease, including HIV positivity or AIDS-related illness
• severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for study entry
• prior chemotherapy for melanoma, except for chemotherapy given during isolated limb perfusion for stage IIIC disease

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Pfizer: collaborator
• Schering-Plough: collaborator

Study Sites (1)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Interventions

Sunitinib; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles

Study Officials

• Bartosz Chmielowski, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: December 1, 2008
• Primary Completion: January 17, 2018
• Study Completion: January 17, 2018
• Last Updated: August 3, 2020

Record last verified: 2018-04

Locations

US (1)