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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00423644
• Other study ID #: SGL2001b
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 16, 2007
• Last updated: November 13, 2013
• Start date: January 2007
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. 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:

1. Serum M-protein level > 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.

2. Urinary M-protein excretion > 0.2 g/24 hours by urine electrophoresis.

2. 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;

3. Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;

4. ECOG performance score = 1;

5. 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.

6. Age = 18;

7. Granulocytes = 1.0 x 109/L; platelets = 50 x 109/L;

8. Bilirubin = 2.0 mg/dL; AST and ALT = 2 x ULN;

9. Creatinine = 3 X ULN.

10. No investigational agents within 28 days of study entry.

11. 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).

Exclusion Criteria

1. 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;

2. Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)

3. Active infection requiring antibiotics;

4. Allergy to ZIO-101 or its excipients;

5. Baseline confusion or dementia, defined as grade > 2 CTCAE Version 3.0;

6. Significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per CTCAE Version 3.0;

7. Prior seizures = grade-3 in CTC v.3 criteria.

8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		6 months	No
Secondary	Survival (overall and progression free)		6 months	Yes
Secondary	toxicities		6 months	Yes