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Alkylating agent

MM-398 + Cyclophosphamide for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by South Plains Oncology Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug combo to see what the highest safe dose is.

Eligible Conditions
  • Refractory or Recurrent Solid Tumors
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Ewing Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities
Secondary outcome measures
Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide

Trial Design

1Treatment groups
Experimental Treatment
Group I: MM-398 + cyclophosphamideExperimental Treatment1 Intervention
MM-398+cyclophosphamide

Find a Location

Who is running the clinical trial?

South Plains Oncology ConsortiumLead Sponsor
6 Previous Clinical Trials
49 Total Patients Enrolled
Paul Harker-Murray, MDStudy ChairMidwest Children's Hospital

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02013336 — Phase 1
Solid Tumors Research Study Groups: MM-398 + cyclophosphamide
Solid Tumors Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02013336 — Phase 1
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02013336 — Phase 1

Frequently Asked Questions

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

How can I become involved in this particular medical experiment?

"This medical trial is enrolling 30 minors aged between 12 months and 20 who have been diagnosed with osteosarcoma. In addition, they must meet the following requirements: histological/cytological confirmation of Ewing sarcoma, rhabdomyosarcoma, neuroblastoma or osteosarcoma; evidence of progression after prior therapy in advanced or metastatic setting; measurable/evaluable disease based on RECIST v1.1 criteria; adequate bone marrow reserves, liver function and renal function; full recovery from any prior surgery or cancer treatment regimens. Patients over 18 years will provide written consent while"

Answered by AI

What pathologies is the combination of MM-398 and cyclophosphamide most often utilized to address?

"Small cell lung cancer is frequently remedied through MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide. Additionally, this combination has been demonstrated to aid in the treatment of various afflictions such as multiple sclerosis, acute myelocytic leukemia, and colorectal carcinoma."

Answered by AI

How many participants have enrolled in the research thus far?

"Affirmative. The clinical trial's entry on clinicaltrials.gov states that they are currently searching for participants, which was posted in December 2013 and last updated in March 2022. A total of 30 individuals need to be recruited from 7 separate sites."

Answered by AI

How many establishments are piloting this trial?

"Participating patients can now enroll at 7 different clinical sites, with 3 of them located in Dallas, Oklahoma City and Cincinnati respectively. To reduce travel burden on those involved, it is advised that they choose the nearest site possible."

Answered by AI

Has there been any prior research conducted on the combined use of MM-398 and cyclophosphamide?

"MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide was first trialed in 1997 at City of Hope Comprehensive Cancer Center. Subsequently, 1593 trials have been completed and 1065 are still active, the majority taking place out of Dallas, Oklahoma."

Answered by AI

Are any further participants being welcomed for this experiment?

"To date, this clinical trial is seeking participants. It was first advertised on December 1st 2013 and the most recent update to its information occurred on March 17th 2022 according to data available through clinicaltrials.gov."

Answered by AI

Does this study include elderly participants?

"The prerequisites for participating in this research are that patients must be between 12 months old and 20 years old. On the other hand, there exist 705 trials involving minors and 1857 studies concerning individuals above 65."

Answered by AI

Has the regulatory agency accepted MM-398 alongside cyclophosphamide?

"Our analytics at Power assigned a score of 1 to the combination therapy MM-398 (Irinotecan Sucrosofate Liposome Injection) and cyclophosphamide due its Phase 1 status, which indicates that there is only limited data available on safety and effectiveness."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
UT Southwestern
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Apr 2025