QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

NCT01029873 | Completed Phase 1 DMC

• 2 other identifiers: CA-ALT-801-02-09R44CA097550
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.

Conditions

Metastatic Melanoma

Keywords

cancer; immunotherapy; targeted; metastatic; interleukin-2; IL-2; Cisplatin; antitumor; melanoma; TCR; T-cell receptor; p53; p53 gene; p53 tumor suppressor protein

Outcome Measures

Primary Outcomes (4)

• To evaluate the safety of the ALT-801-Cisplatin regimen.

  12 months

• To assess the objective response (OR) which includes CR and PR.

  3 months

• To assess the clinical benefit (CB) of the ALT-801-Cisplatin regimen which includes CR, PR and SD.

  3 months

• To determine the MTD of the ALT-801-Cisplatin regimen.

  7 weeks

Secondary Outcomes (2)

• To assess the six-month and one-year survival rates.

  12 months

• To evaluate the immunogenicity and pharmacokinetic profile of ALT-801.

  2 months

Study Arms (1)

ALT-801

EXPERIMENTAL

Drug: Cisplatin; Biological: ALT-801

Interventions

Cisplatin DRUG

Intravenous infusions; 2 treatment courses; 2 treatment cycles for each course; 70mg/m2 on day 1 of cycle 1 for each course

ALT-801

ALT-801 BIOLOGICAL

Intravenous infusions; cycle 1: day 3 and 5; cycle 2: day 1, 3 and 5; nine day rest period between cycles; seven day recovery period between courses Stage 1: dose escalation (0.04 mg/kg, 0.06 mg/kg, 0.08 mg/kg) Stage 2: dose expansion (dose at MTD)

ALT-801

Eligibility Criteria

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

ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic melanoma * Measurable * Histologically or cytologically confirmed * Surgically incurable * HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT THERAPY: * If prior Proleukin treatment, must have had clinical benefit * No prior systemic cytotoxic chemotherapy for melanoma * No concurrent radiotherapy, chemotherapy, or other immunotherapy * More than 4 weeks since prior major radiotherapy * More than 8 weeks since prior CTLA-4 antagonist immunotherapy * Not receiving other investigational agents PATIENT CHARACTERISTICS: Life expectancy * \> 3 months Performance status * ECOG 0 or 1 Bone marrow reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL * Platelets ≥100,000/uL * Hemoglobin ≥ 10g/dL Renal function * Serum creatinine ≤ 1.5 mg/dL Hepatic function * Total bilirubin ≤ 1.5 X ULN * AST ≤ 2.5 X ULN * Alkaline phosphatase ≤ 2.5 X ULN * PT INR ≤ 1.5 X ULN * aPTT ≤ 1.5 X ULN Cardiovascular * May be safely tapered off anti-hypertensives if currently on anti-hypertensives * New York Heart Association classification I or II * No congestive heart failure \<6 months * No unstable angina pectoris \<6 months * No myocardial infarction \<6 months * No history of ventricular arrhythmias * Normal cardiac stress test required if any of the following is present: * Age ≥ 50 * History of abnormal EKG * Symptoms of cardiac ischemia or arrhythmia Pulmonary * Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following is present: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction Other * No known autoimmune disease * No known HIV positive * No psychiatric illness/social situations that would limit study compliance * No history or evidence of CNS disease * No active systemic infection requiring parental antibiotic therapy * No systemic steroid therapy required * No prior organ allograft or allogeneic transplantation * Not receiving chronic medication for asthma * Not pregnant or nursing * Fertile patients must use effective contraception

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Altor BioScience: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Carolinas Medical Center-Brumenthal Cancer Center

Charlotte, North Carolina, 28204, United States

Location

St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

University of Washington, Seattle Cancer Care Center

Seattle, Washington, 98109, United States

Location

Related Links

• Altor Bioscience Corporation, Miramar, Florida, US

MeSH Terms

Conditions

Melanoma; Neoplasms; Neoplasm Metastasis

Interventions

Cisplatin; ALT-801

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hing Wong, PhD

  Altor BioScience

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: February 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: September 1, 2013
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (8)