MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide for Osteosarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern, Dallas, TX
Osteosarcoma+6 More
MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may help treat certain types of cancer.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide will improve 1 primary outcome and 1 secondary outcome in patients with Osteosarcoma. Measurement will happen over the course of 12 months.

12 months
Measurement of plasma levels of study drug to determine the pharmacokinetic properties of MM-398 in combination with cyclophosphamide
To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

MM-398 + cyclophosphamide
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Cyclophosphamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

MM-398 + cyclophosphamide
Drug
MM-398+cyclophosphamide

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

UT Southwestern - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Osteosarcoma or one of the other 6 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically-confirmed Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, or osteosarcoma
Disease progression after prior therapy in locally advanced or metastatic setting
Measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
Age 12 months to <21 years
Adequate bone marrow reserves, hepatic function, and renal function
Recovered from effects of any prior surgery or cancer therapy
Patients 18 years or older will provide written consent. A parent or legal guardian of a patient <18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy.

Patient Q&A Section

What are common treatments for osteosarcoma?

"Patients with osteosarcomas of the proximal humerus and extremity are the most likely to receive surgical fixation, whereas patients with metaphyseal lesions are more likely to receive chemotherapy. The majority of patients undergoing amputation at this institution receive adjuvants chemotherapy in addition to amputation." - Anonymous Online Contributor

Unverified Answer

How many people get osteosarcoma a year in the United States?

"Approximately 4,600 people in the United States are projected to be diagnosed with osteosarcoma each year. In addition, approximately 15,300 osteosarcoma cases are expected to be diagnosed in the US each year. These numbers represent a significant increase from the number of osteosarcoma cases currently being diagnosed in the US (1990) (1,060), and represent an increasing trend in incidence of the disease to be seen by 2050." - Anonymous Online Contributor

Unverified Answer

What is osteosarcoma?

"Osteosarcoma is one of the most common and challenging solid tumors, including those with the most fatalities. The 5-year survival rates of children with Ewing's sarcomas are 70-85%." - Anonymous Online Contributor

Unverified Answer

Can osteosarcoma be cured?

"Only when patients are treated appropriately and after a sufficiently long follow-up can osteosarcoma be cured. Today, cure of osteosarcoma in children is not possible. Cure can only be achieved through adequate and adequate therapy with a long-term follow-up." - Anonymous Online Contributor

Unverified Answer

What causes osteosarcoma?

"Osteosarcoma is associated with the following factors: young age, nonunion after a fractured limb and a positive family history. It probably occurs as a result of a genetically inherited predisposition." - Anonymous Online Contributor

Unverified Answer

What are the signs of osteosarcoma?

"All of the signs discussed can be indicative of the presence of osteosarcoma. A history of trauma may be present in cases where the tumor is found during preoperative investigation." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for osteosarcoma?

"The overall 5-year survival rate was 70.0%, and is similar to that reported in the literature for Ewing's sarcoma as a whole. For patients with Stage IV Ewing's sarcoma, a high percentage (32%) will have some residual disease at the time of autopsy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of osteosarcoma?

"Overall, it appears that a predisposition of the tumor can be established by a variable combination of environmental conditions, and the genetic defect. It should be considered that other sarcoma types may also be caused to develop in situations of environmental stress." - Anonymous Online Contributor

Unverified Answer

Is mm-398 (irinotecan sucrosofate liposome injection) plus cyclophosphamide safe for people?

"It was concluded that this combination is not toxic and would therefore be possible for people with metastatic Ewing's sarcoma to be given during the course of treatment even if they were previously receiving methotrexate plus doxorubicin. Results from a recent paper also demonstrate that no extra effects of the induction of the HPMN occur when cyclophosphamide is added to the concurrent chemotherapy regimen of irinotecan and cyclophosphamide." - Anonymous Online Contributor

Unverified Answer

How quickly does osteosarcoma spread?

"Data from a recent study of this present study indicate that the rate of tumor progression is high after surgery among the short survivors. To improve patient care it might be advisable to follow the patients with imaging exams every 3 mo to determine the size and rate of disease progression so that possible adjuvant treatment could have a broader impact on the patient's course of illness." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets osteosarcoma?

"We found that there is a peak occurrence of osteosarcoma cases at the very end of adolescence, which coincides with the average age for sexual activity. For example, osteosarcoma is one of the most common cancers in adolescents and adolescents, and more specifically in males than females. However, it is more frequent in males aged 16 to 19 years of age than females. Osteosarcoma cases are more prevalent in the United States, and especially in people between the ages of 15 and 19. Osteosarcoma is a rare disease in children. It is estimated that only 75 to 80 out of every million people a year are affected by this disease when it erupts in adults." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing osteosarcoma?

"The chance of developing osteosarcoma in a Caucasian is 1.3 times that of developing it in any other race. The same disparity also exists regarding the specific sites of osteosarcoma of the limb. The most common sites for osteosarcoma development are in the ribs, pelvis and scapula, this shows that osteosarcoma generally arises in places where most cases in Caucasian people can be expected to manifest (e.g. rib, pelvis, scapula, etc.). However, we can conclude that the chance of developing osteosarcoma in any given site of the skeleton is the same for all races." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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