A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b

NCT00423644 | Unknown Phase 2

• 1 other identifier: SGL2001b
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 8

Brief Summary

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; arsenic; cancer study; failed treatment

Outcome Measures

Primary Outcomes (1)

• Response Rate

  6 months

Secondary Outcomes (2)

• Survival (overall and progression free)

  6 months

• toxicities

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Darinaparson

Interventions

Darinaparson DRUG

420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months

Also known as: ZIO-101

Single Arm

Eligibility Criteria

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

You may qualify if:

• Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
• Serum M-protein level \> 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.
• Urinary M-protein excretion \> 0.2 g/24 hours by urine electrophoresis.
• Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after \> 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
• Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
• ECOG performance score ≤ 1;
• No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
• Age ≥ 18;
• Granulocytes ≥ 1.0 x 109/L; platelets ≥ 50 x 109/L;
• Bilirubin ≤ 2.0 mg/dL; AST and ALT ≤ 2 x ULN;
• Creatinine ≤ 3 X ULN.
• No investigational agents within 28 days of study entry.
• Males who agree to use a double-barrier method of birth control, (Double barrier method is defined as: a condom and either a diaphragm/cervical cap or an IUD).

You may not qualify if:

• NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
• Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
• Active infection requiring antibiotics;
• Allergy to ZIO-101 or its excipients;
• Baseline confusion or dementia, defined as grade \> 2 CTCAE Version 3.0;
• Significant neurotoxicityneuropathology, defined as grade \> 2 neurotoxicity neuropathology per CTCAE Version 3.0;
• Prior seizures ≥ grade-3 in CTC v.3 criteria.
• Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (8)

Unknown Facility

Glendale, Arizona, United States

Location

Unknown Facility

Santa Barbara, California, United States

Location

Unknown Facility

Santa Rosa, California, United States

Location

Unknown Facility

West Hollywood, California, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

darinaparsin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (8)