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Alkylating agents

Chemotherapy + Stem Cell Transplant for Solid Cancers

Phase 1
Waitlist Available
Led By Anna Pawlowska, MD
Research Sponsored by City of Hope Medical Center
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 1 year post stem cell rescue
Awards & highlights

Study Summary

This trial is studying a combination of drugs as a possible treatment for patients with solid tumors.

Who is the study for?
This trial is for patients with certain solid tumors like neuroblastoma or sarcomas, who've responded to previous treatments. They must have good heart, lung, liver, and kidney function and not be at high risk from the treatment. Pregnant women or those not using birth control are excluded, as are HIV patients and anyone previously treated with similar intense therapy.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs (busulfan, melphalan, topotecan hydrochloride) followed by a stem cell transplant in patients with new or returning solid tumors. It aims to see how well this approach works after initial tumor shrinkage from other treatments.See study design
What are the potential side effects?
Potential side effects include damage to bone marrow leading to low blood counts; mouth sores; nausea; vomiting; diarrhea; hair loss; liver problems such as increased enzymes and bilirubin levels; lung complications like difficulty breathing or reduced oxygen levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post stem cell rescue
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post stem cell rescue for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment feasibility in terms of investigational agent-related adverse events of a novel treatment combination followed by peripheral blood stem cell rescue
Secondary outcome measures
Disease-free survival
Incidence of myeloid and platelet engraftment
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment8 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melphalan
1994
Completed Phase 3
~3530
filgrastim
1997
Completed Phase 3
~7260
autologous bone marrow transplantation
1997
Completed Phase 3
~3880
busulfan
1999
Completed Phase 3
~3630
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
topotecan hydrochloride
1996
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,435 Total Patients Enrolled
Anna Pawlowska, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00638898 — Phase 1
Central Nervous System Tumor Research Study Groups: Arm I
Central Nervous System Tumor Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT00638898 — Phase 1
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00638898 — Phase 1

Frequently Asked Questions

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

Has the FDA authorized autologous hematopoietic stem cell transplantation?

"Assessing its safety on a 1 to 3 scale, autologous hematopoietic stem cell transplantation received a score of one due to the limited amount of data available for this Phase 1 trial."

Answered by AI

Is this clinical research accepting new participants at the moment?

"At this time, recruitment for this clinical trial has ended. Initially posted on February 26th 2007 with the last update being March 17th 2022, individuals seeking to participate in trials related to ewing sarcoma or autologous hematopoietic stem cell transplantation may have better luck; there are presently 4358 and 365 active studies respectively recruiting patients."

Answered by AI

Is this clinical research endeavor open to adults aged 18 and older?

"This clinical trial is enrolling participants aged between 6 months and 40 years."

Answered by AI

What are the criteria for individuals to be selected for this research?

"This clinical study is recruiting 25 paediatric patients between 6 months and 40 years of age that have been diagnosed with ewing sarcoma. To be eligible, participants must meet the following criteria: Have attempted to achieve a complete or partial response; pre-transplant modalities may include surgery, chemotherapy, or radiation therapy (excluding lung fields); only patients in CR/PR at the primary site can participate; histological confirmation from an Anatomic Pathology Department for recurrent/metastatic disease; no contraindications to stem cell collection via apheresis or bone marrow harvesting; signed voluntary informed consent according to institutional & federal guidelines"

Answered by AI

In what cases do doctors usually advise autologous hematopoietic stem cell transplantation?

"Autologous hematopoietic stem cell transplantation is a therapeutic option for acute myelocytic leukemia, allogeneic hematopoietic stem cell transplant, chronic myelogenous leukemia, sarcoma and essential thrombocythemia."

Answered by AI

How many participants are currently undergoing the therapy being tested in this trial?

"At this time, the study in question is not accepting participants. This medical trial was initially posted on February 26th of 2007 and updated most recently on March 17th of 2022. If you are looking for alternative studies to join, there are currently 4358 ewing sarcoma-related trials open as well as 365 autologous hematopoietic stem cell transplantation experiments actively enrolling patients."

Answered by AI
~1 spots leftby Apr 2025