Trial Outcomes & Findings for Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection (NCT NCT00668382)

Results Overview

Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

1 month

Results posted on

2013-05-15

Participant Flow

Patients recruited from medical and surgical oncology clinics with currently untreatable tumors from march 2007 through June 2011

No assignment to separate arms, Patients had to be off any active treatment for their advanced tumors for at least 2 weeks before entry onto study and a month after. Two subjects withdrew after screening and consent because of stroke (1) and insurance refusal(1). Two patients dropped out in the first month due to treatment needs.

Participant milestones

Participant milestones
Measure	Alpha-Gal Glycosphingolipid Injection Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alpha-Gal Glycosphingolipid Injection n=11 Participants Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	60 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Dose escalating Phase 1 scheme: three participants for each dose cohort. The second patient in the last (10 mg) dose cohort developed and adverse event (infection at injection site) and so three more participants were entered and analyzed at that dose

Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection

Outcome measures

Outcome measures
Measure	Intratumoral Injection n=11 Participants Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
Number of Subjects With Greater Than Grade 3 or 4 Toxicity	1 participants

Adverse Events

Intratumoral Injection

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intratumoral Injection n=11 participants at risk Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
Surgical and medical procedures surgical site infection	9.1% 1/11 • Number of events 1 • Over one month patients followed for as long as they lived per clinical care protocols

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheila Noone

UMass Medical Scool

Phone: 508 856 5015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place