Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003630
Arsenic Trioxide in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing arsenic trioxide in people with Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- arsenic trioxide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Aug 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Relapsed from or resistant to at least 1 course of standard anticancer therapy AND/OR Lack of standard therapy that is known to be beneficial in the underlying disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 months following study No active serious infections that are not controlled by antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase I Study of Arsenic Trioxide
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. III. Evaluate evidence of clinical responsiveness to this treatment regimen.
OUTLINE: This is a dose escalation, open label study. Patients are stratified by age (pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. Patients are followed for at least 1 month after treatment.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- arsenic trioxide
- Keywords
- unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2004 (estimated)
- Study startAug 1998
- Primary completionAug 2000
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven Soignet, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003630
- Sponsor's protocol ID
- 98-046
- Other IDs
- CDR0000066713, NCI-G98-1479
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Arsenic Trioxide
- ClinicalTrials.gov ID
- NCT00003630
- Acronym / sponsor ID
- 98-046
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 24 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. III. Evaluate evidence of clinical responsiveness to this treatment regimen.
OUTLINE: This is a dose escalation, open label study. Patients are stratified by age (pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. Patients are followed for at least 1 month after treatment.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arsenic trioxide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
Related trials for Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Soignet, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing arsenic trioxide in people with Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013; AzTrials last refreshed its copy on 31 Oct 2026.