← Back to Search

Radiopharmaceutical

CycloSam® for Bone Cancer

Phase 1

Recruiting

Research Sponsored by QSAM Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

Awards & highlights

Study Summary

This trial tests the safety and how much CycloSam® can be safely given as two doses to treat bone tumors.

Who is the study for?

This trial is for people aged 15-75 with bone cancer or tumors that have spread to the bones, visible on a bone scan. They must have tried other treatments without cure and be in stable condition with good organ function. Contraception is required during and after treatment.Check my eligibility

What is being tested?

The study tests different doses of CycloSam® (Samarium-153-DOTMP), a drug that targets radiation to bones, to find the highest dose patients can tolerate without severe side effects. Participants receive two rounds of this radiopharmaceutical therapy.See study design

What are the potential side effects?

Potential side effects include temporary low calcium levels which might cause muscle cramps or tingling sensations. Since it's radiation-based, there may also be risks similar to those associated with other forms of radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity Rate (DLT)

Secondary outcome measures

Bone Tumor Efficacy - Clinical Response Rate

Overall Survival

Pain Palliation

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Level 4Experimental Treatment1 Intervention

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 3.0 mCi/kg

Group II: Dose Level 3Experimental Treatment1 Intervention

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 2.0 mCi/kg

Group III: Dose Level 2Experimental Treatment1 Intervention

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 1.0 mCi/kg

Group IV: Dose Level 1Experimental Treatment1 Intervention

Everyone gets a first dose of 0.5 mCi/kg dose and then in 7 days a second dose of 0.5 mCi/kg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

QSAM Therapeutics, Inc.Lead Sponsor

Barry SugarmanStudy DirectorQSAM Therapeutics, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be considered an ideal participant in this research endeavor?

"Eligible candidates should have bone cancer and meet the age criteria of 15 to 75 years old. 17 participants are needed for this research endeavour."

Answered by AI

Is Dose Level 1 considered to be a safe dosage for patients?

"Assigned a rating of 1 on the safety scale, Dose Level 1 has not yet been exposed to extensive clinical testing. Therefore, there is only minimal data available regarding its efficacy and security."

Answered by AI

Do individuals aged 35 and above qualify for enrollment in this trial?

"This clinical trial seeks patients aged between 15 and 75, with 439 studies available to those younger than 18 and 3,119 for participants over 65."

Answered by AI

Are there any current opportunities to join this research endeavor?

"According to information on clinicaltrials.gov, this medical research is actively enlisting volunteers with the first post being dated April 5th 2022 and an update occurring 18 August 2023."

Answered by AI

What is the capacity of this research trial and how many participants have been recruited?

"That is correct. According to the clinicaltrials.gov website, this trial was initially advertised on April 5th 2022 and most recently updated on August 18th 2023. The study necessitates 17 participants from 3 different sites for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Finding Study to Treat Bone Tumor(s)

2022. "A Dose Finding Study to Treat Bone Tumor(s)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008483.

All > Montreal > Bone Cancer